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Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis (COBALT)

Primary Purpose

Liver Cirrhosis, Biliary

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Obeticholic Acid (OCA)
Placebo
Sponsored by
Intercept Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis, Biliary focused on measuring Primary Biliary Cirrhosis, PBC, Cirrhosis, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Diseases [AASLD] and the European Association for the Study of the Liver [EASL] practice guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:

    • History of elevated Alkaline phosphatase levels for at least 6 months
    • Positive antimitochondrial antibody (AMA) titer or if AMA negative or in low titer (<1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
    • Liver biopsy consistent with PBC
  2. A mean total bilirubin >ULN and ≤5x ULN and/or a mean ALP >3x ULN
  3. Either is not taking UDCA (no UDCA dose in the past 3 months) or has been taking UDCA for at least 12 months with a stable dose for ≥3 months prior to Day 0

Exclusion Criteria:

  1. History or presence of other concomitant liver diseases including:

    • Hepatitis C virus infection
    • Active Hepatitis B infection; however, subjects who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
    • Primary sclerosing cholangitis (PSC)
    • Alcoholic liver disease
    • Definite autoimmune liver disease or overlap hepatitis
    • Nonalcoholic steatohepatitis (NASH)
    • Gilbert's Syndrome

  2. Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:

    • History of liver transplant, current placement on a liver transplant list, or current Model of End Stage Liver Disease (MELD) score >12. Subjects who are placed on a transplant list despite a relatively early disease stage (for example per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria

    • Cirrhosis with complications, including history (within the past 12 months) or presence of:

      • Variceal bleed
      • Uncontrolled ascites
      • Encephalopathy
      • Spontaneous bacterial peritonitis
    • Known or suspected HCC
    • Prior transjugular intrahepatic portosystemic shunt procedure
    • Hepatorenal syndrome (type I or II) or screening (Visit 1 or 2) serum creatinine >2 mg/dL (178 μmol/L)
  3. Mean total bilirubin >5x ULN
  4. Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures
  5. Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions)
  6. If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
  7. Known history of human immunodeficiency virus infection
  8. Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months)
  9. Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
  10. History of alcohol abuse or other substance abuse within 1 year prior to Day 0
  11. Participation in another investigational product, biologic, or medical device study within 30 days prior to Screening. Participation in a previous study of OCA is allowed with 3 months washout prior to enrollment in this study
  12. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain
  13. History of known or suspected clinically significant hypersensitivity to OCA or any of its components
  14. UDCA naïve (unless contraindicated)

Sites / Locations

  • Mayo Clinic Arizona
  • Cedars-Sinai Medical Center
  • Inland Empire Liver Foundation
  • University of California Davis, Davis Medical Center
  • Stanford University
  • University of Colorado Denver and Hospital
  • UF Hepatology Research at CTRB
  • Schiff Center for Liver Diseases/University of Miami
  • Piedmont Atlanta Hospital
  • Emory University Hospital
  • Gastrointestinal Specialists of Georgia
  • Northwestern University Feinberg School of Medicine
  • University of Chicago Medical Center
  • Indiana University
  • Indianapolis Gastroenterology Research Foundation
  • University of Louisville, Medical Dental Complex
  • Tulane University Medical Center
  • Mercy Medical Center
  • UMass Medical School
  • Henry Ford Health System
  • Minnesota Gastroenterology, P.A.
  • Southern Therapy and Advanced Research (STAR)
  • Kansas City Research Institute
  • Saint Louis University Gastroenterology & Hepatology
  • Saint Joseph's Regional Medical Center
  • Mount Sinai Beth Israel
  • Weill Cornell Medical College
  • University of Rochester Medical Center
  • Hospital of the University of Pennsylvania
  • Quality Medical Research, PLLC
  • The Liver Institute at Methodist Dallas Medical Center
  • Baylor University Medical Center
  • Texas Digestive Disease Consultants
  • UT Southwestern Medical Center
  • Brooke Army Medical Center
  • Baylor Scott and White Research Institute
  • Baylor College of Medicine - Advanced Liver Therapies
  • UT Health The University of Texas Health Science Center at Houston
  • American Research Corporation at Texas Liver Institute
  • Texas Digestive Disease Consultants
  • Clinical Research Centers of America
  • McGuire DVAMC
  • Swedish Organ Transplant & Liver Center
  • Centro De Hepatología
  • Hospital Universitario Austral
  • Dim Clínica Privada
  • Hospital Privado Universitario de Cordoba S.A.
  • Hospital Provincial del Centenario
  • CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.
  • Hospital De Clinicas University Of Buenos Aires
  • Centrol Integral de Gastroenterologia
  • Hospital Italiano de Buenos Aires
  • Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
  • Hospital Aleman
  • Hospital Britanico De Buenos Aires
  • AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital
  • Department of Gastroenterology & Hepatology, Nepean Hospital
  • Gallipoli Medical Research Foundation
  • Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
  • Flinders Medical Centre
  • Box Hill Hospital
  • St. Vincent's Hospital Melbourne
  • Austin Hospital
  • Fiona Stanley Hospital, Gastroenterology Department
  • AKH, Medical University of Vienna
  • University Hospital Antwerp
  • Uz Leuven
  • Cub Hôpital Erasme
  • University Hospital Ghent
  • Hospital Sao Rafael
  • Gastrocentro/ Universidade Estadual de Campinas (UNICAMP)
  • Instituto Hospital de Base do Distrito Federal-IHBDF
  • Instituto Goiano de Gastroenterologia
  • Cepec Huufma
  • Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG)
  • Hospital de Clinicas de Porto Alegre
  • Hospital Universitario Professor Edgard Santos
  • Gastrocentro. Unidad Estadual de CAmpinas UNICAMP
  • Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
  • St. Ivan Rilsky University Hospital
  • University of Calgary Liver Unit (Heritage Medical Research Clinic)
  • University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC)
  • University Of Manitoba, Health Sciences Centre
  • London Health Sciences Centre-University Hospital
  • University Health Network, Toronto General Hospital
  • Chum
  • Centro De Investigaciones Clínicas Viña Del Mar
  • Aarhus University Hospital Department of Hepatology and Gastroenterology
  • Medicinsk klinik for mave, tarm-og leversygdomme
  • Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S
  • East Tallinn Central Hospital Gastroenterology Center
  • Tartu University Hospital
  • Helsinki University Central Hospital
  • Turku University Central Hospital, Gastroenterology Outpatient Clinic
  • Hospital Saint-Antoine, A.P.-H.P.
  • CHRU Hôpital HURIEZ
  • Chu De Bordeaux - Hôpital Haut Lévêque
  • Klinikum der Johann-Wolfgang Goethe, Universitaet Frankfurt am Main
  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
  • Friedrich-Alexander-Uniersitat Erlangen
  • CHARITÉ, Campus Virchow Klinikum
  • Univeritatsklinikum Hamburg Eppendorf, Medizinische Klinik und Poliklinik
  • Universitaetsklinikum Heidelberg Medizinische Universitaetsklinik
  • Universität Leipzig KöR, Medizinische Fakultät
  • University of Munich, LMU Klinikum Grosshadern
  • Queen Mary Hospital
  • Prince Of Wales Hospital
  • Tuen Mun Hospital
  • Alice Ho Miu Ling Nethersole Hospital
  • Humanity & Health Research Centre
  • Békés Megyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
  • Szent János Hospital
  • University Of Debrecen, Department Of Medicine, Division Of Gastroenterology
  • Hadassah Hebrew University Medical Center
  • Soroka Medical Center
  • Rambam Health Care Campus
  • Shaare Zedek Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Sourasky Tel-Aviv Medical Center
  • Azienda Ospedaliero - Universitaria di Cagliari - Centro per lo Studio delle Malattie del Fegato
  • Università Politecnica delle Marche - Azienda Ospedaliero
  • AOU Policlinico Sant' Orsola Malpighi
  • Azienda Ospedaliero Universitaria Sant´ Orsola Malpighi
  • Azienda Ospedaliero Universitaria Careggi Universita di Firenze
  • Azienda Socio-Sanitarla Territoriale (ASST) Santi Paolo e Carlo
  • AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica
  • Azienda Socio Sanitaria Territoriale (ASST) di Monza
  • Azienda Ospedaliero - Universita di Padova
  • AOU Policlinico Paolo Giaccone - Di.Bi.M.I.S
  • Policlinico Universitario Agostino Gemelli - Universita Cattolica del Sacro Cuore
  • Inje University Busan Paik Hospital
  • Gangnam Severance Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Pusan National University Hospital
  • Hospital of Lithuanian University of Health Sciences, Kauno klinikos
  • Vilnius University Hospital Santaros klinikos
  • Medica Sur, S.A.B. de C.V.
  • Departamento De Gastroenterologia. Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
  • Consultorio Médico de la Dra Alma Laura Ladrón de Guevara Cetina
  • Radboud UMC
  • Vrije Universiteit Medisch Centrum (VUMC)
  • Erasmus Mc
  • Amsterdam University Medical Centre (AMC)
  • University Medical Center Utrecht
  • NZ Liver Transplant Unit, Auckland Hospital
  • Gastroenterology, Christchurch Hospital
  • Nzoz Vitamed
  • Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego, Pierwszy Oddzial Chorob Zakaznych
  • Medical University of Warsaw Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie (SPCSK in Warsaw
  • Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii Onkologicznej
  • Oddział Gastr. I Hepat. Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibińskiego Sum
  • Dep. Of Gastroenterology UM Lublin
  • Centro Hospitalar Lisboa Norte, EPE - Hospital de Santa Maria
  • Clinic For Gastroenterology And Hepatology Clinical Center Of Serbia
  • Clinical Hospital Centre Zvezdara
  • Hospital Universitario Marqués De Valdecilla
  • Hospital Universitario Puerta De Hierro Majadahonda
  • Hospital Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Virgen De La Victoria University Hospital
  • Hospital Universitario Virgen del Rocio
  • La Fe, Hospital ( Valence )
  • Karolinska University Hospital
  • Sahlgrenska Universitetssjukhuset
  • Inselspital, University Of Bern, UVCM, DMLL
  • Kantonsspital St. Gallen, Clinic for Gastroeterologie and Hepatologie
  • USZ, Klinik für Gastroenterologie und Hepatologie
  • Ankara University School of Medicine Gastroenterology Dept.
  • Ege University School of Medicine Gastroenterology Dept.
  • University Hospitals Bristol NHS Foundation Trust
  • Plymouth Hospitals NHS Trust, Derriford Hospital
  • Gartnavel General Hospital
  • Forth Valley Royal Hospital
  • Institute of Cellular Medicine
  • University Hospitals Birmingham NHS Foundation Trust
  • Cambrigde University Hospitals NHS Foundation Trust
  • The Royal Free Hospital
  • Nottingham University Hospital Nhs Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Obeticholic Acid (OCA) 5 mg to 10 mg

Placebo

Arm Description

Obeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).

Outcomes

Primary Outcome Measures

Time to the First Occurrence of Composite Endpoint
To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) ≥15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), or spontaneous bacterial peritonitis. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% confidence intervals (CIs) for the clinical events distribution percentiles (25th and 50th) are provided.
Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint)
Primary clinical outcome event is the first occurrence of the following events: death, liver transplant, MELD score >=15 (MELD-Na score >=12 baseline), MELD-Na score >=15 (MELD-Na score <12 baseline), hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis), or bacterial empyema, uncontrolled or refractory ascites (requiring large volume paracentesis), portal hypertension syndromes, progression to decompensated liver disease, and progression to clinical evidence of portal hypertension without decompensation (for participants without decompensation or clinical evidence of portal hypertension at baseline). 71 endpoint events were observed in the OCA arm, and 80 were observed in the Placebo arm. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.

Secondary Outcome Measures

Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint
The first occurrence of the key secondary clinical event refers to the first occurrence of the following events: death, liver transplant, MELD-Na score >=15 if MELD-Na< 12 at baseline, MELD score >=15 if MELD-Na >=12 at baseline, uncontrolled or refractory ascites, portal hypertension syndromes (hepatorenal syndrome, portopulmonary syndrome, hepatopulmonary syndrome) or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis, or bacterial empyema. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
Time To Liver Transplant Or Death (All-cause)
The effect of OCA compared to placebo on time to liver transplant or death (all-cause) was assessed. The events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
Time to First Occurrence of Fatal Event (All-Cause)
The results represent the ratio of OCA to placebo. The fatal events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the fatal events distribution percentiles (25th and 50th) are provided
Time to First Occurrence of Liver Transplant
The effect of OCA compared to placebo on time to occurrence of a liver transplant was assessed. The results represented the ratio of OCA to placebo. A hazard ratio <1 indicated an advantage for OCA. The event of interest was summarized through Cumulative Incidence Function (CIF) estimate at 5 years.
Time to First Occurrence of Hospitalization Due to Hepatic Events
Hospitalization events include new onset or recurrent variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis OR presence of >250/mm^3 polymorph leucocytes [PMNs] in the ascitic fluid), bacterial empyema is confirmed by diagnostic thoracentesis OR presence of >250/mm^3 PMNs in the pleural fluid. The event of interest was summarized through CIF estimate at 5 years.
Time to First Occurrence of Uncontrolled or Refractory Ascites
Uncontrolled or refractory ascites are defined as diuretic-resistant ascites requiring large-volume paracentesis. The effect of OCA compared to placebo on time to the first occurrence of uncontrolled or refractory ascites was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time to First Occurrence of MELD Score ≥15
The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and International Normalized Ratio (INR), as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.
Time To Development Of Varix/Varices
The effect of OCA compared to placebo on time to development of varix/varices was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time To Liver-Related Death
The effect of OCA compared to placebo on time to liver-related death was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time To Liver-Related Death Or Liver Transplant
The effect of OCA compared to placebo on time to liver-related death or liver transplant was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time To Liver-Related Death, Liver Transplant, Or MELD Score ≥15
The effect of OCA compared to placebo on time to liver-related death, liver transplant, or MELD Score ≥15 was assessed. The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.
Progression To Cirrhosis (for Noncirrhotic Subjects at Baseline)
When a participant is identified as noncirrhotic at the Baseline and exhibited any signs or symptoms associated with progression to cirrhosis, the participant was assessed by Fibroscan® TE where available. The event of interest was summarized through CIF estimate at 5 years.
Time To Occurrence Of Hepatocellular Carcinoma (HCC)
The effect of OCA compared to placebo on time to occurrence of HCC was assessed. The event of interest was summarized through CIF estimate at 5 years.
Change From Baseline To Month 24 Of Total Bilirubin
Liver biochemistry, which includes total bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using mixed model repeated measures (MMRM), including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 24 Of Direct Bilirubin
Liver biochemistry, which includes direct bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 24 Of Aspartate Aminotransferase (AST)
Liver biochemistry, which includes AST, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 24 Of Alanine Aminotransferase (ALT)
Liver biochemistry, which includes ALT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 24 Of Alkaline Phosphatase (ALP)
Liver biochemistry, which includes ALP, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 24 Of Gamma-glutamyl Transferase (GGT)
Liver biochemistry, which includes GGT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 24 Of Albumin
Liver biochemistry, which includes albumin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 24 Of INR
The coagulation test, which includes INR, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. INR is the ratio of tested prothrombin time to normal prothrombin time, to a power designated the international sensitivity index (ISI). INR normal range is 0.8 to 1.2 (female and male). Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Change From Baseline To Month 72 Of MELD Score
The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.
Change From Baseline To Month 72 Of MELD-Na Score
The MELD-Na score is another useful predictor in assessing participants with significant decompensation. The MELD-Na took into account the effect of serum sodium as a reflection of renal function and hypothetically may improve the accuracy of the model score. The MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and serum sodium, as appropriate, to predict survival. The MELD-Na score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.
Change From Baseline To Month 72 Of CPS
Child-Pugh Score (Pugh 1973, Lucey 1997) was calculated and reported within the electronic data capture (EDC) system based on data entered into the CRF by adding the scores from the 5 factors and could have ranged from 5 to15. A total score of 5 to 6 was considered Grade A (mild, well-compensated disease); 7 to 9 was Grade B (moderate, significant functional compromise); and 10 and above was Grade C (severe, decompensated disease).
Change From Baseline To Month 72 Of Mayo Risk Score (MRS)
Mayo Risk Score (MRS) was calculated and reported within the EDC system. Calculation of MRS included Investigator assessment of peripheral edema and the use of diuretic therapy, which was assessed during the adverse event and concomitant medicine review at the scheduled visits and entered into the CRF, as well as total bilirubin, albumin, and prothrombin time results obtained from the central laboratory data. There is no maximum and minimum range of score but an increase in the MRS represents an increase in the risk of death.
Change From Baseline To Month 72 Of Immunoglobulin-M (IgM)
Markers of inflammation, which include IgM, were assessed.
Change From Baseline To Month 72 Of C-reactive Protein (CRP)
Markers of inflammation, which include CRP, were assessed.
Change From Baseline To Month 72 Of Tumor Necrosis Factor-α (TNF-α)
Markers of inflammation, which include TNF-α, were assessed.
Change From Baseline To Month 72 Of Fibroblast Growth Factor-19 (FGF-19)
Markers of hepatic fibrosis, which include FGF-19, were assessed.
Change From Baseline To Month 72 Of Cytokeratin-18 (CK-18)
Markers of inflammation, which include CK-18, were assessed.
Change From Baseline To Month 72 Of 7α-hydroxy-4-cholesten-3-one (C4)
Markers of hepatic fibrosis, which include C4, were assessed.
Change From Baseline To Month 72 Of Enhanced Liver Fibrosis (ELF)
Liver fibrosis was assessed using ELF test. The ELF test assessed: hyaluronic acid, procollagen3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1. The ELF test is a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline suggests decreased fibrosis.
Change From Baseline To Month 72 Of Liver Stiffness - Transient Elastography
Hepatic stiffness was measured using non-invasive transient Elastography with Fibroscan® TE device.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Pharmacokinetic (PK) Population: Fasting Trough Concentrations Of OCA By Dose Regimen
The fasting trough PK concentrations of OCA of different dose regimens taken throughout the study are reported.
PK Population: Serial Concentration of OCA By Dose Regimen
In Month 9, blood samples were collected at predose, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h and PK serial concentrations at different dose regimen are reported.
PK Population: Area Under The Concentration-Time Curve (AUC) From 0 to 6 Hours Post-dose (AUC0-6h) Of Participants Who Received 5 mg QD OCA and With CP Score=Non-Cirrhotic (NC)
In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
PK Population: AUC From 0 to 24 Hours Post-dose (AUC0-24h) Of Participants Who Received 5 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
PK Population: Maximum Observed Concentration (Cmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
PK Population: Time to Cmax (Tmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
PK Population: Metabolite to Parent Ratio of AUC0-6h (MRAUC) Of Participants Who Received 5mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
PK Population: Metabolite to Parent Ratio of Cmax (MRCmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
PK Population: Cmax Of Participants Who Received 5mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
PK Population: Tmax Of Participants Who Received 5mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
PK Population: Concentration at 24 Hours Post-dose (Ctrough) Of Participants Who Received 5mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
PK Population: MRAUC Of Participants Who Received 5mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
PK Population: MRCmax Of Participants Who Received 5mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
PK Population: Ctrough Of Participants Who Received 5mg QD OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=B.
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC
PK Population: Cmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
PK Population: Tmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
PK Population: Ctrough Of Participants Who Received 5mg QOD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
PK Population: MRAUC Of Participants Who Received 5mg QOD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
PK Population: MRCmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CPS Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CPS Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
PK Population: Cmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
PK Population: Tmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
PK Population: Ctrough Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
PK Population: MRAUC Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
PK Population: MRCmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QD OCA
The trough concentration of OCA in the cirrhotic participants who received 5 mg QD OCA was reported.
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QD OCA
The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QD OCA was reported.
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QOD OCA
The trough concentration of OCA in the cirrhotic participants who received 5 mg QOD OCA was reported.
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QOD OCA
The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QOD OCA was reported.
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QW OCA
The trough concentration of OCA in the cirrhotic participants who received 5 mg QW OCA was reported.
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QW OCA
In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 5 QW QOD OCA was reported.
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg Q2W OCA
The trough concentration of OCA in the cirrhotic participants who received 5 mg Q2W OCA was reported.
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg Q2W OCA
The trough concentration of OCA in the non-cirrhotic participants who received 5 Q2W QOD OCA was reported.
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QD OCA
The trough concentration of OCA in the cirrhotic participants who received 10 mg QD OCA was reported.
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QD OCA
The trough concentration of OCA in the non-cirrhotic participants who received 10 QD QOD OCA was reported.
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QOD OCA
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QOD OCA
In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg QOD OCA was reported.
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg Q2W OCA
In Month 6, the trough concentration of OCA in the cirrhotic participants who received 10 mg Q2W OCA was reported.
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg Q2W OCA
In Month 6, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg Q2W OCA was reported.

Full Information

First Posted
November 10, 2014
Last Updated
February 13, 2023
Sponsor
Intercept Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02308111
Brief Title
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Acronym
COBALT
Official Title
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
The DMC made the recommendation to not pursue further enrollment given the lack of feasibility for this post-marketing study as designed.
Study Start Date
December 26, 2014 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intercept Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.
Detailed Description
This Phase 4, double-blind, randomized, placebo-controlled, multicenter study is being undertaken at up to 170 sites internationally to evaluate the effect of OCA on clinical outcomes in 428 participants with PBC. The study will include a screening period of up to 8 weeks, requiring two clinic visits. Eligible participants will be randomly allocated (1:1) to treatment with either OCA 5 mg or matching placebo tablets, taken orally once daily for the majority of participants; dose and frequency will be modified for participants with cirrhosis and classified as Child-Pugh (CP) B or C. Randomization will be stratified by standard treatment with UDCA (yes/no) and baseline liver function. The treatment period involves clinic visits approximately every 3 months. At the 3 month visit or any study visit thereafter, if study treatment is tolerated, participants' dose should be titrated per protocol in a blinded manner eg for participants who are non-cirrhotic or classified as CP A and randomized to OCA, they should receive the maximum daily dose of 10 mg OCA, those on placebo continue to receive placebo. Subsequently, daily dosage may return to 5 mg if necessary for these participants who are non-cirrhotic or classified as CP A, but should be increased to 10 mg if possible, based on tolerability and clinical judgment. Safety and tolerability will be assessed by monitoring adverse events and vital signs, and blood and urine testing. The study is event driven and total duration will be determined by the time required to accrue approximately 127 primary endpoint events, estimated to be approximately 10 years. Participants are expected to have a minimum follow-up time of approximately 6 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Biliary
Keywords
Primary Biliary Cirrhosis, PBC, Cirrhosis, Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obeticholic Acid (OCA) 5 mg to 10 mg
Arm Type
Experimental
Arm Description
Obeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Obeticholic Acid (OCA)
Other Intervention Name(s)
6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747
Intervention Description
Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One tablet daily (or a lower frequency depending on CP score) for the remainder of the study
Primary Outcome Measure Information:
Title
Time to the First Occurrence of Composite Endpoint
Description
To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) ≥15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), or spontaneous bacterial peritonitis. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% confidence intervals (CIs) for the clinical events distribution percentiles (25th and 50th) are provided.
Time Frame
Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)
Title
Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint)
Description
Primary clinical outcome event is the first occurrence of the following events: death, liver transplant, MELD score >=15 (MELD-Na score >=12 baseline), MELD-Na score >=15 (MELD-Na score <12 baseline), hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis), or bacterial empyema, uncontrolled or refractory ascites (requiring large volume paracentesis), portal hypertension syndromes, progression to decompensated liver disease, and progression to clinical evidence of portal hypertension without decompensation (for participants without decompensation or clinical evidence of portal hypertension at baseline). 71 endpoint events were observed in the OCA arm, and 80 were observed in the Placebo arm. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
Time Frame
Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)
Secondary Outcome Measure Information:
Title
Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint
Description
The first occurrence of the key secondary clinical event refers to the first occurrence of the following events: death, liver transplant, MELD-Na score >=15 if MELD-Na< 12 at baseline, MELD score >=15 if MELD-Na >=12 at baseline, uncontrolled or refractory ascites, portal hypertension syndromes (hepatorenal syndrome, portopulmonary syndrome, hepatopulmonary syndrome) or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis, or bacterial empyema. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
Time Frame
Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years)
Title
Time To Liver Transplant Or Death (All-cause)
Description
The effect of OCA compared to placebo on time to liver transplant or death (all-cause) was assessed. The events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
Time Frame
Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years)
Title
Time to First Occurrence of Fatal Event (All-Cause)
Description
The results represent the ratio of OCA to placebo. The fatal events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the fatal events distribution percentiles (25th and 50th) are provided
Time Frame
Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years)
Title
Time to First Occurrence of Liver Transplant
Description
The effect of OCA compared to placebo on time to occurrence of a liver transplant was assessed. The results represented the ratio of OCA to placebo. A hazard ratio <1 indicated an advantage for OCA. The event of interest was summarized through Cumulative Incidence Function (CIF) estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years)
Title
Time to First Occurrence of Hospitalization Due to Hepatic Events
Description
Hospitalization events include new onset or recurrent variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis OR presence of >250/mm^3 polymorph leucocytes [PMNs] in the ascitic fluid), bacterial empyema is confirmed by diagnostic thoracentesis OR presence of >250/mm^3 PMNs in the pleural fluid. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years)
Title
Time to First Occurrence of Uncontrolled or Refractory Ascites
Description
Uncontrolled or refractory ascites are defined as diuretic-resistant ascites requiring large-volume paracentesis. The effect of OCA compared to placebo on time to the first occurrence of uncontrolled or refractory ascites was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of first documented uncontrolled or refractory ascites, liver transplant or date of death from any cause, whichever came first (up to 5 years)
Title
Time to First Occurrence of MELD Score ≥15
Description
The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and International Normalized Ratio (INR), as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of first documented MELD Score ≥15, liver transplant or date of death from any cause, whichever came first (up to 5 years)
Title
Time To Development Of Varix/Varices
Description
The effect of OCA compared to placebo on time to development of varix/varices was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of first documented development of varix/varices, liver transplant or death from any cause, whichever came first (up to 5 years)
Title
Time To Liver-Related Death
Description
The effect of OCA compared to placebo on time to liver-related death was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of first liver-related or non-liver- related death, whichever came first (up to 5 years)
Title
Time To Liver-Related Death Or Liver Transplant
Description
The effect of OCA compared to placebo on time to liver-related death or liver transplant was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of liver transplant, liver-related death or non-liver-related death from any cause, whichever came first (up to 5 years)
Title
Time To Liver-Related Death, Liver Transplant, Or MELD Score ≥15
Description
The effect of OCA compared to placebo on time to liver-related death, liver transplant, or MELD Score ≥15 was assessed. The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of liver transplant, liver-related death, non-liver-related death from any cause or MELD Score ≥15, whichever came first (up to 5 years)
Title
Progression To Cirrhosis (for Noncirrhotic Subjects at Baseline)
Description
When a participant is identified as noncirrhotic at the Baseline and exhibited any signs or symptoms associated with progression to cirrhosis, the participant was assessed by Fibroscan® TE where available. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of cirrhosis, liver transplant or death from any cause, whichever came first (up to 5 years)
Title
Time To Occurrence Of Hepatocellular Carcinoma (HCC)
Description
The effect of OCA compared to placebo on time to occurrence of HCC was assessed. The event of interest was summarized through CIF estimate at 5 years.
Time Frame
Time to first occurrence from date of randomization until the date of HCC diagnosis, liver transplant or death from any cause, whichever came first (up to 5 years)
Title
Change From Baseline To Month 24 Of Total Bilirubin
Description
Liver biochemistry, which includes total bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using mixed model repeated measures (MMRM), including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 24 Of Direct Bilirubin
Description
Liver biochemistry, which includes direct bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 24 Of Aspartate Aminotransferase (AST)
Description
Liver biochemistry, which includes AST, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 24 Of Alanine Aminotransferase (ALT)
Description
Liver biochemistry, which includes ALT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 24 Of Alkaline Phosphatase (ALP)
Description
Liver biochemistry, which includes ALP, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 24 Of Gamma-glutamyl Transferase (GGT)
Description
Liver biochemistry, which includes GGT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 24 Of Albumin
Description
Liver biochemistry, which includes albumin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 24 Of INR
Description
The coagulation test, which includes INR, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. INR is the ratio of tested prothrombin time to normal prothrombin time, to a power designated the international sensitivity index (ISI). INR normal range is 0.8 to 1.2 (female and male). Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
Time Frame
Baseline up to Month 24
Title
Change From Baseline To Month 72 Of MELD Score
Description
The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of MELD-Na Score
Description
The MELD-Na score is another useful predictor in assessing participants with significant decompensation. The MELD-Na took into account the effect of serum sodium as a reflection of renal function and hypothetically may improve the accuracy of the model score. The MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and serum sodium, as appropriate, to predict survival. The MELD-Na score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of CPS
Description
Child-Pugh Score (Pugh 1973, Lucey 1997) was calculated and reported within the electronic data capture (EDC) system based on data entered into the CRF by adding the scores from the 5 factors and could have ranged from 5 to15. A total score of 5 to 6 was considered Grade A (mild, well-compensated disease); 7 to 9 was Grade B (moderate, significant functional compromise); and 10 and above was Grade C (severe, decompensated disease).
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of Mayo Risk Score (MRS)
Description
Mayo Risk Score (MRS) was calculated and reported within the EDC system. Calculation of MRS included Investigator assessment of peripheral edema and the use of diuretic therapy, which was assessed during the adverse event and concomitant medicine review at the scheduled visits and entered into the CRF, as well as total bilirubin, albumin, and prothrombin time results obtained from the central laboratory data. There is no maximum and minimum range of score but an increase in the MRS represents an increase in the risk of death.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of Immunoglobulin-M (IgM)
Description
Markers of inflammation, which include IgM, were assessed.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of C-reactive Protein (CRP)
Description
Markers of inflammation, which include CRP, were assessed.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of Tumor Necrosis Factor-α (TNF-α)
Description
Markers of inflammation, which include TNF-α, were assessed.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of Fibroblast Growth Factor-19 (FGF-19)
Description
Markers of hepatic fibrosis, which include FGF-19, were assessed.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of Cytokeratin-18 (CK-18)
Description
Markers of inflammation, which include CK-18, were assessed.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of 7α-hydroxy-4-cholesten-3-one (C4)
Description
Markers of hepatic fibrosis, which include C4, were assessed.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of Enhanced Liver Fibrosis (ELF)
Description
Liver fibrosis was assessed using ELF test. The ELF test assessed: hyaluronic acid, procollagen3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1. The ELF test is a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline suggests decreased fibrosis.
Time Frame
Baseline up to Month 72
Title
Change From Baseline To Month 72 Of Liver Stiffness - Transient Elastography
Description
Hepatic stiffness was measured using non-invasive transient Elastography with Fibroscan® TE device.
Time Frame
Baseline up to Month 72
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time Frame
Baseline up to the last IP dose plus 30 days and prior to commercial OCA initiation date (up to 7 years)
Title
Pharmacokinetic (PK) Population: Fasting Trough Concentrations Of OCA By Dose Regimen
Description
The fasting trough PK concentrations of OCA of different dose regimens taken throughout the study are reported.
Time Frame
Months 3, 6, 9, 12, 24, 36, 48, and 60
Title
PK Population: Serial Concentration of OCA By Dose Regimen
Description
In Month 9, blood samples were collected at predose, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h and PK serial concentrations at different dose regimen are reported.
Time Frame
Month 9
Title
PK Population: Area Under The Concentration-Time Curve (AUC) From 0 to 6 Hours Post-dose (AUC0-6h) Of Participants Who Received 5 mg QD OCA and With CP Score=Non-Cirrhotic (NC)
Description
In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: AUC From 0 to 24 Hours Post-dose (AUC0-24h) Of Participants Who Received 5 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Maximum Observed Concentration (Cmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Time to Cmax (Tmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Metabolite to Parent Ratio of AUC0-6h (MRAUC) Of Participants Who Received 5mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Metabolite to Parent Ratio of Cmax (MRCmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 5mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 5mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: Concentration at 24 Hours Post-dose (Ctrough) Of Participants Who Received 5mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 5mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 5mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 5mg QD OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=B.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CPS Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CPS Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Description
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Time Frame
Month 9
Title
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QD OCA
Description
The trough concentration of OCA in the cirrhotic participants who received 5 mg QD OCA was reported.
Time Frame
Months 3, 6, 12, 24, and 48
Title
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QD OCA
Description
The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QD OCA was reported.
Time Frame
Months 3, 6, 9, 12, and 24
Title
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QOD OCA
Description
The trough concentration of OCA in the cirrhotic participants who received 5 mg QOD OCA was reported.
Time Frame
Months 6, 12, and 24
Title
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QOD OCA
Description
The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QOD OCA was reported.
Time Frame
Months 3, 6, and 12
Title
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QW OCA
Description
The trough concentration of OCA in the cirrhotic participants who received 5 mg QW OCA was reported.
Time Frame
Months 6 and 12
Title
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QW OCA
Description
In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 5 QW QOD OCA was reported.
Time Frame
Month 12
Title
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg Q2W OCA
Description
The trough concentration of OCA in the cirrhotic participants who received 5 mg Q2W OCA was reported.
Time Frame
Months 6, 24, 36 and 48
Title
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg Q2W OCA
Description
The trough concentration of OCA in the non-cirrhotic participants who received 5 Q2W QOD OCA was reported.
Time Frame
Months 3, 6, 12, 24, 36, and 48
Title
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QD OCA
Description
The trough concentration of OCA in the cirrhotic participants who received 10 mg QD OCA was reported.
Time Frame
Months 6, 9, 12, 24, 36, and 60
Title
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QD OCA
Description
The trough concentration of OCA in the non-cirrhotic participants who received 10 QD QOD OCA was reported.
Time Frame
Months 6, 9, 12, 24, and 36
Title
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QOD OCA
Time Frame
Months 3, 6, 9, 12, 24, 36, 48, and 60
Title
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QOD OCA
Description
In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg QOD OCA was reported.
Time Frame
Month 12
Title
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg Q2W OCA
Description
In Month 6, the trough concentration of OCA in the cirrhotic participants who received 10 mg Q2W OCA was reported.
Time Frame
Month 6
Title
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg Q2W OCA
Description
In Month 6, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg Q2W OCA was reported.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Diseases [AASLD] and the European Association for the Study of the Liver [EASL] practice guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of ≥2 of the following 3 diagnostic factors: History of elevated Alkaline phosphatase levels for at least 6 months Positive antimitochondrial antibody (AMA) titer or if AMA negative or in low titer (<1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]) Liver biopsy consistent with PBC A mean total bilirubin >ULN and ≤5x ULN and/or a mean ALP >3x ULN Either is not taking UDCA (no UDCA dose in the past 3 months) or has been taking UDCA for at least 12 months with a stable dose for ≥3 months prior to Day 0 Exclusion Criteria: History or presence of other concomitant liver diseases including: Hepatitis C virus infection Active Hepatitis B infection; however, subjects who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor Primary sclerosing cholangitis (PSC) Alcoholic liver disease Definite autoimmune liver disease or overlap hepatitis Nonalcoholic steatohepatitis (NASH) Gilbert's Syndrome Presence of clinical complications of PBC or clinically significant hepatic decompensation, including: History of liver transplant, current placement on a liver transplant list, or current Model of End Stage Liver Disease (MELD) score >12. Subjects who are placed on a transplant list despite a relatively early disease stage (for example per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria Cirrhosis with complications, including history (within the past 12 months) or presence of: Variceal bleed Uncontrolled ascites Encephalopathy Spontaneous bacterial peritonitis Known or suspected HCC Prior transjugular intrahepatic portosystemic shunt procedure Hepatorenal syndrome (type I or II) or screening (Visit 1 or 2) serum creatinine >2 mg/dL (178 μmol/L) Mean total bilirubin >5x ULN Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions) If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating Known history of human immunodeficiency virus infection Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months) Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study History of alcohol abuse or other substance abuse within 1 year prior to Day 0 Participation in another investigational product, biologic, or medical device study within 30 days prior to Screening. Participation in a previous study of OCA is allowed with 3 months washout prior to enrollment in this study Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain History of known or suspected clinically significant hypersensitivity to OCA or any of its components UDCA naïve (unless contraindicated)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Ness, MD
Organizational Affiliation
Intercept Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
University of California Davis, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Denver and Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UF Hepatology Research at CTRB
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Schiff Center for Liver Diseases/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33163
Country
United States
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Louisville, Medical Dental Complex
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Saint Louis University Gastroenterology & Hepatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Saint Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Quality Medical Research, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Baylor Scott and White Research Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine - Advanced Liver Therapies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UT Health The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Research Corporation at Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Clinical Research Centers of America
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Swedish Organ Transplant & Liver Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Centro De Hepatología
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902AWL
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Presidente Derqui
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Facility Name
Dim Clínica Privada
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
1704
Country
Argentina
Facility Name
Hospital Privado Universitario de Cordoba S.A.
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Hospital Provincial del Centenario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.
City
Buenos Aires
ZIP/Postal Code
1119
Country
Argentina
Facility Name
Hospital De Clinicas University Of Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1120
Country
Argentina
Facility Name
Centrol Integral de Gastroenterologia
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
1264
Country
Argentina
Facility Name
Hospital Aleman
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Hospital Britanico De Buenos Aires
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Department of Gastroenterology & Hepatology, Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Gallipoli Medical Research Foundation
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Fiona Stanley Hospital, Gastroenterology Department
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
AKH, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Uz Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cub Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hospital Sao Rafael
City
São Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Gastrocentro/ Universidade Estadual de Campinas (UNICAMP)
City
Sao Paulo
State/Province
Campinas
ZIP/Postal Code
13083-878
Country
Brazil
Facility Name
Instituto Hospital de Base do Distrito Federal-IHBDF
City
Brasilia
State/Province
Distrito Federal Brazil
ZIP/Postal Code
70335-900
Country
Brazil
Facility Name
Instituto Goiano de Gastroenterologia
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Cepec Huufma
City
Sao Luis
State/Province
Maranhao
ZIP/Postal Code
65020-600
Country
Brazil
Facility Name
Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG)
City
Belo Horizonte,
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Universitario Professor Edgard Santos
City
Bahia
State/Province
Salvador
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Gastrocentro. Unidad Estadual de CAmpinas UNICAMP
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-878
Country
Brazil
Facility Name
Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO
City
Rio de Janeiro
ZIP/Postal Code
20270-004
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
St. Ivan Rilsky University Hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University of Calgary Liver Unit (Heritage Medical Research Clinic)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N-4Z6
Country
Canada
Facility Name
University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
University Of Manitoba, Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P6
Country
Canada
Facility Name
London Health Sciences Centre-University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Chum
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Centro De Investigaciones Clínicas Viña Del Mar
City
Viña Del Mar
State/Province
V Región
ZIP/Postal Code
2540488
Country
Chile
Facility Name
Aarhus University Hospital Department of Hepatology and Gastroenterology
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Medicinsk klinik for mave, tarm-og leversygdomme
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
East Tallinn Central Hospital Gastroenterology Center
City
Tallinn
State/Province
Harju
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Turku University Central Hospital, Gastroenterology Outpatient Clinic
City
Turku,
ZIP/Postal Code
20521
Country
Finland
Facility Name
Hospital Saint-Antoine, A.P.-H.P.
City
Paris Cedex 12
State/Province
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHRU Hôpital HURIEZ
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Chu De Bordeaux - Hôpital Haut Lévêque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Klinikum der Johann-Wolfgang Goethe, Universitaet Frankfurt am Main
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Friedrich-Alexander-Uniersitat Erlangen
City
Erlangen
State/Province
QLD
ZIP/Postal Code
91054
Country
Germany
Facility Name
CHARITÉ, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Univeritatsklinikum Hamburg Eppendorf, Medizinische Klinik und Poliklinik
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg Medizinische Universitaetsklinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universität Leipzig KöR, Medizinische Fakultät
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University of Munich, LMU Klinikum Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Pokfulam
Country
Hong Kong
Facility Name
Prince Of Wales Hospital
City
Hong Kong
State/Province
Shatin
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Hong Kong
State/Province
Tuen Mun, New Territories
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Humanity & Health Research Centre
City
Hong Kong
Country
Hong Kong
Facility Name
Békés Megyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
City
Bekescsaba
ZIP/Postal Code
H-5600
Country
Hungary
Facility Name
Szent János Hospital
City
Budapest
ZIP/Postal Code
H-1125
Country
Hungary
Facility Name
University Of Debrecen, Department Of Medicine, Division Of Gastroenterology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Hadassah Hebrew University Medical Center
City
Jerusalem
State/Province
Nazareth Elit
ZIP/Postal Code
POB 12000, 91120
Country
Israel
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
84104
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031 02
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52656 01
Country
Israel
Facility Name
Sourasky Tel-Aviv Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliero - Universitaria di Cagliari - Centro per lo Studio delle Malattie del Fegato
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
Facility Name
Università Politecnica delle Marche - Azienda Ospedaliero
City
Ancona
ZIP/Postal Code
71-60126
Country
Italy
Facility Name
AOU Policlinico Sant' Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Sant´ Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi Universita di Firenze
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Socio-Sanitarla Territoriale (ASST) Santi Paolo e Carlo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica
City
Modena
ZIP/Postal Code
41126
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale (ASST) di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliero - Universita di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
AOU Policlinico Paolo Giaccone - Di.Bi.M.I.S
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Inje University Busan Paik Hospital
City
Busan
State/Province
Busanjin-gu
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-Gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Hospital of Lithuanian University of Health Sciences, Kauno klinikos
City
Kaunas
ZIP/Postal Code
LT 50009
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Medica Sur, S.A.B. de C.V.
City
Ciudad de mexico
State/Province
Ciudad De Mexico,
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Departamento De Gastroenterologia. Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
City
Mexico City
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Consultorio Médico de la Dra Alma Laura Ladrón de Guevara Cetina
City
Mexico City
State/Province
DF
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Radboud UMC
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum (VUMC)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Erasmus Mc
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Amsterdam University Medical Centre (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
NZ Liver Transplant Unit, Auckland Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Gastroenterology, Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
4710
Country
New Zealand
Facility Name
Nzoz Vitamed
City
Bydgoszcz
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
85-078
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego, Pierwszy Oddzial Chorob Zakaznych
City
Wroclaw
State/Province
Lover Silesia
ZIP/Postal Code
51-149
Country
Poland
Facility Name
Medical University of Warsaw Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie (SPCSK in Warsaw
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii Onkologicznej
City
Warsaw
State/Province
Mazovia
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Oddział Gastr. I Hepat. Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibińskiego Sum
City
Katowice
State/Province
Silesia
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Dep. Of Gastroenterology UM Lublin
City
Lublin
ZIP/Postal Code
20-094
Country
Poland
Facility Name
Centro Hospitalar Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Clinic For Gastroenterology And Hepatology Clinical Center Of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Centre Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Hospital Universitario Marqués De Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Puerta De Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Virgen De La Victoria University Hospital
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
La Fe, Hospital ( Valence )
City
Valence
ZIP/Postal Code
46026
Country
Spain
Facility Name
Karolinska University Hospital
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Inselspital, University Of Bern, UVCM, DMLL
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital St. Gallen, Clinic for Gastroeterologie and Hepatologie
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
USZ, Klinik für Gastroenterologie und Hepatologie
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Ankara University School of Medicine Gastroenterology Dept.
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Ege University School of Medicine Gastroenterology Dept.
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust, Derriford Hospital
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Forth Valley Royal Hospital
City
Larbert
State/Province
Scotland
ZIP/Postal Code
FK5 4WR
Country
United Kingdom
Facility Name
Institute of Cellular Medicine
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Cambrigde University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
The Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Nottingham University Hospital Nhs Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19554543
Citation
Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
Results Reference
background
PubMed Identifier
19501929
Citation
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.
Results Reference
background

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Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

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