Back to resultsRESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Primary Purpose
Primary Biliary Cholangitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seladelpar 10 mg
Placebo
Seladelpar 5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring Primary Biliary Cholangitis (PBC), PBC
Eligibility Criteria
Inclusion Criteria:
- Must have given written informed consent (signed and dated) and any authorizations required by local law
- 18 to 75 years old (inclusive)
- Male or female with a definitive diagnosis of PBC
- UDCA for the past 12 months (stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening)
Laboratory parameters measured by the Central Laboratory at screening:
- ALP ≥1.67× ULN
- Aspartate aminotransferase (AST) ≤3× ULN
- ALT ≤3× ULN
- Total bilirubin ≤2× ULN
- Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease study equation)
- International normalized ratio (INR) below 1.1× ULN For subjects on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease.
- Platelet count ≥100×103/µL
NOTE: PT, INR, and platelets can be performed locally at the Screening Visit, if deemed necessary by the investigator after consultation with the medical monitor, in cases where centrally read samples are deemed invalid.
- Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Exclusion Criteria:
- Previous exposure to seladelpar (MBX-8025).
- A medical condition other than PBC that, in the investigator's opinion, would preclude full participation in the study (e.g., cancer) or confound its results (e.g., Paget's disease, any active infection).
- Advanced PBC as defined by the Rotterdam criteria (albumin below the lower limit of normal AND total bilirubin above 1.0× ULN)
Presence of clinically important hepatic decompensation, including the following:
- History of liver transplantation, current placement on liver transplantation list, or current Model for End-Stage Liver Disease (MELD) score ≥12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with their current dose adjustments of their anticoagulant medication, will be taken into account when calculating the MELD score. This will be done in consultation with the medical monitor.
- Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (ege.g., transjugular intrahepatic portosystemic shunt placement), ascites, and hepatic encephalopathy.
- Cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis, hepatocellular carcinoma, or hepatorenal syndrome.
Other chronic liver diseases:
- Current features of AIH as determined by the investigator based on immunoserology, liver biochemistry, or historic confirmed liver histology.
- PSC determined by the presence of diagnostic cholangiographic findings.
- History or clinical evidence of alcoholic liver disease.
- History or clinical evidence of alpha-1-antitrypsin deficiency.
- History of biopsy confirmed NASH.
- History or evidence of Gilbert's syndrome with elevated total bilirubin.
- History or evidence of hemochromatosis.
- Hepatitis B, defined as the presence of hepatitis B surface antigen.
- Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid.
- History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms.
- Known history of human immunodeficiency virus (HIV) or positive antibody test at screening
- Clinically important alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to quantify alcohol intake reliably.
- History of malignancy diagnosed or treated, actively or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening.
- Treatment with obeticholic acid (OCA) or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) 6 weeks prior to screening
- Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (>2 weeks) during 2 months prior to screening
- Treatment with anti-pruritic drugs (e.g., cholestyramine, naltrexone, rifampicin, sertraline, or any experimental approach) must be on a stable dose within 1 month prior to screening
- Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
- For females, pregnancy or breastfeeding
- Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator
- Immunosuppressant therapies
- Other medications that effect liver or GI functions, such as absorption of medications or the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case-by-case basis.
- Active COVID-19 infection during Screening.
Sites / Locations
- The Institute for Liver Health DBA Arizona Liver Health
- Arkansas Diagnostic Center
- Stanford University School of Medicine
- California Liver Research Institute
- University of California, Davis Medical Center
- California Pacific Medical Center - Sutter Pacific Medical Foundation
- Covenant Metabolic Specialists, LLC
- Florida Research Institute
- Schiff Center for Liver Diseases/University of Miami
- Covenant Research and Clinics, LLC
- Digestive Healthcare of Georgia
- Rush University Medical Center
- University of Chicago Hospitals
- Tulane University Health Sciences Center
- Mercy Medical Center
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Henry Ford Health System
- MNGI Digestive Health, P.A.
- Southern Therapy and Advanced Research, LLC (STAR)
- Saint Louis University
- NYU Langone Health / NYU Grossman School of Medicine
- Weill Cornell Medical College
- Icahn School of Medicine at Mount Sinai
- University of Rochester Medical Center
- Care Access Research - Lumberton
- University Hospitals Cleveland Medical Center
- Penn State Milton S Hershey Medical Center
- UPMC Center for Liver Diseases
- Galen Hepatology
- Gastro One
- Vanderbilt Digestive Disease Center
- The Liver Institute at Methodist Dallas Medical Center
- University of Texas Southwestern Medical Center
- Texas Digestive Disease Consultants dba GI Alliance
- Baylor College of Medicine
- American Research Corporation at the Texas Liver Institute
- Pinnacle Clinical Research, PLLC
- Bon Secours Richmond Community Hospital LLC
- Liver Institute Northwest
- Centro Medico Dra. De Salvo
- STAT Research S.A.
- Hospital Italiano de La Plata
- DIM CliniaPrivada
- CINME (Centro de Investigaciones Metabolicas)
- Hospital Italiano de Buenos Aires
- Concord Repatriation General Hospital
- Royal Brisbane & Women's Hospital
- Alfred Hospital
- The Royal Melbourne Hospital
- Klinikum Wels-Grieskirchen GmbH, Abteilung Fur Innere Medizin I - Gastroenterologie
- UZ Antwerpen
- CHU de Liège
- AZ Maria Middelares
- Universitair Ziekenhuis Gent
- Universitaire Ziekenhuizen Leuven
- London Health Sciences Centre
- University Health Network
- Toronto Digestive Disease Associates Inc
- Centro Clinico Mediterraneo
- Clinical Research Chile SpA
- Centro de Investigaciones Clínicas Vina del Mar
- Fakultni nemocnice Ostrava- Interni a Kardiologicka Klinika, Oddeleni gastroenterologie, hepatologie a pankreatologie
- Aalborg Universitetshospital, Ambulatoriet for Medicinske Mave-Tarm Sygdomme
- Hvidovre Hospital
- CHU de Grenoble
- Hopital de la Croix-Rousse
- Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine
- Universitätsklinikum Bonn
- Universitätsklinikum des Saarlandes
- Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie
- Universitatsklinikum Frankfurt. Medizinische Klinik I
- Ifi-Medizin GmbH
- Gastroenterologische Gemeinschaftspraxis
- Universitatsklinikum Leipzig
- Ippokrateio General Hospital of Athens
- General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases
- Semmelweis Egyetem
- Somogy Megyei Kaposi Mor Oktato Korhaz
- Liver Unit
- Liver Disease Center, Sheba Medical Center
- Institute for Digestive Tract & Liver Disease
- ASST di Monza
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
- Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara
- Azienda Ospedaliero Universitaria Careggi
- Azienda Ospedaliera Universita Padova
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Inje University Busan Paik Hospital
- Soon Chun Hyang University Hospital Bucheon
- Pusan National University Hospital
- Kyungpook National University Hospital
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Center
- Severance Hospital Yonsei University Health System - PPDS
- Consultorio Medico - Distrito Federal
- Consultorio de la Doctora Maria Sarai Gonzalez Huezo
- Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc
- Hospital Universitario Dr. Jose Eleuterio González
- Gastroenterology, Christchurch Hospital
- Gastroenterology Research Unit Dunedin Hospital
- Uniwersyteckie Centrum Kliniczne Im.
- ID Clinic Akradiusz Pisula
- Fundeni Clinical Institute
- State budget institution of healthcare of Moscow city "Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov" of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology
- Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies
- Clinic of High Medical Technologies n.a. N.I. Pirogov
- LLC Medical Company "Hepatolog"
- Stavropol state medical university
- Ulyanovsk Regional Clinical Hospital
- Hospital Universitario German Trias i Pujol
- Hospital Universitario Margues de Valdecilla
- Hospital Universitario Virgen de la Victoria
- Hospital Universitario Vall D'Hebron
- Hospital Clinic de Barcelona
- Hospital Universitario 12 de Octubre
- University of Zurich, Gastroenterology and Hepatology
- Ankara Gazi University Faculty of Medicine Hospital
- Ankara Sehir Hastanesi
- Bezmi Alem University
- Marmara University Pendik Training and Research Hospital
- Ege University Medical Faculty
- Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council
- Medical Center OK!Clinic+LLC International Institute of Clinical Research
- University Hospitals Plymouth NHS Trust
- Portsmouth Hospitals NHS Trust
- Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
- Queen's Medical Centre
- Gemini Clinical Trial Unit
- University Hospitals Birmingham NHS Foundation Trust, Heritage Building (Queen Elizabeth Hospital)
- Hull Royal Infirmary
- Kings College Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Seladelpar 10 mg
Placebo
Seladelpar 5 mg
Arm Description
Outcomes
Primary Outcome Measures
Composite endpoint of ALP and total bilirubin
ALP < 1.67× ULN,
≥ 15% decrease in ALP, and
Total bilirubin ≤1.0× ULN
Secondary Outcome Measures
Normalization of ALP
Proportion of subjects with ALP ≤1.0× ULN
Change in baseline numerical rating scale (NRS)
Weekly averaged pruritus NRS in subjects with baseline NRS ≥4. The NRS is a scale of 0 (no itching) to 10 (worst imaginable itching)
Full Information
NCT ID
NCT04620733
First Posted
November 4, 2020
Last Updated
September 26, 2023
Sponsor
CymaBay Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04620733
Brief Title
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Official Title
RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
August 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CymaBay Therapeutics, Inc.
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
To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis
Keywords
Primary Biliary Cholangitis (PBC), PBC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seladelpar 10 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Seladelpar 5 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Seladelpar 10 mg
Intervention Description
Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule daily for double-blind period, for a duration of up to 12 months
Intervention Type
Drug
Intervention Name(s)
Seladelpar 5 mg
Intervention Description
If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months
Primary Outcome Measure Information:
Title
Composite endpoint of ALP and total bilirubin
Description
ALP < 1.67× ULN,
≥ 15% decrease in ALP, and
Total bilirubin ≤1.0× ULN
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Normalization of ALP
Description
Proportion of subjects with ALP ≤1.0× ULN
Time Frame
12 months
Title
Change in baseline numerical rating scale (NRS)
Description
Weekly averaged pruritus NRS in subjects with baseline NRS ≥4. The NRS is a scale of 0 (no itching) to 10 (worst imaginable itching)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have given written informed consent (signed and dated) and any authorizations required by local law
18 to 75 years old (inclusive)
Male or female with a definitive diagnosis of PBC
UDCA for the past 12 months (stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening)
Laboratory parameters measured by the Central Laboratory at screening:
ALP ≥1.67× ULN
Aspartate aminotransferase (AST) ≤3× ULN
ALT ≤3× ULN
Total bilirubin ≤2× ULN
Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease study equation)
International normalized ratio (INR) below 1.1× ULN For subjects on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease.
Platelet count ≥100×103/µL
NOTE: PT, INR, and platelets can be performed locally at the Screening Visit, if deemed necessary by the investigator after consultation with the medical monitor, in cases where centrally read samples are deemed invalid.
Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Exclusion Criteria:
Previous exposure to seladelpar (MBX-8025).
A medical condition other than PBC that, in the investigator's opinion, would preclude full participation in the study (e.g., cancer) or confound its results (e.g., Paget's disease, any active infection).
Advanced PBC as defined by the Rotterdam criteria (albumin below the lower limit of normal AND total bilirubin above 1.0× ULN)
Presence of clinically important hepatic decompensation, including the following:
History of liver transplantation, current placement on liver transplantation list, or current Model for End-Stage Liver Disease (MELD) score ≥12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with their current dose adjustments of their anticoagulant medication, will be taken into account when calculating the MELD score. This will be done in consultation with the medical monitor.
Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (ege.g., transjugular intrahepatic portosystemic shunt placement), ascites, and hepatic encephalopathy.
Cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis, hepatocellular carcinoma, or hepatorenal syndrome.
Other chronic liver diseases:
Current features of AIH as determined by the investigator based on immunoserology, liver biochemistry, or historic confirmed liver histology.
PSC determined by the presence of diagnostic cholangiographic findings.
History or clinical evidence of alcoholic liver disease.
History or clinical evidence of alpha-1-antitrypsin deficiency.
History of biopsy confirmed NASH.
History or evidence of Gilbert's syndrome with elevated total bilirubin.
History or evidence of hemochromatosis.
Hepatitis B, defined as the presence of hepatitis B surface antigen.
Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid.
History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms.
Known history of human immunodeficiency virus (HIV) or positive antibody test at screening
Clinically important alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to quantify alcohol intake reliably.
History of malignancy diagnosed or treated, actively or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening.
Treatment with obeticholic acid (OCA) or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) 6 weeks prior to screening
Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (>2 weeks) during 2 months prior to screening
Treatment with anti-pruritic drugs (e.g., cholestyramine, naltrexone, rifampicin, sertraline, or any experimental approach) must be on a stable dose within 1 month prior to screening
Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
For females, pregnancy or breastfeeding
Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator
Immunosuppressant therapies
Other medications that effect liver or GI functions, such as absorption of medications or the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case-by-case basis.
Active COVID-19 infection during Screening.
Facility Information:
Facility Name
The Institute for Liver Health DBA Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arkansas Diagnostic Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center - Sutter Pacific Medical Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Covenant Metabolic Specialists, LLC
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Schiff Center for Liver Diseases/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Covenant Research and Clinics, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Tulane University Health Sciences 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
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
MNGI Digestive Health, P.A.
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55117
Country
United States
Facility Name
Southern Therapy and Advanced Research, LLC (STAR)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
NYU Langone Health / NYU Grossman School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
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
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
Care Access Research - Lumberton
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28358
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
UPMC Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Galen Hepatology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt Digestive Disease Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
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
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Digestive Disease Consultants dba GI Alliance
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Research Corporation at the Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Pinnacle Clinical Research, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Bon Secours Richmond Community Hospital LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Centro Medico Dra. De Salvo
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
STAT Research S.A.
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AX
Country
Argentina
Facility Name
DIM CliniaPrivada
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
CINME (Centro de Investigaciones Metabolicas)
City
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Klinikum Wels-Grieskirchen GmbH, Abteilung Fur Innere Medizin I - Gastroenterologie
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU de Liège
City
Liege
State/Province
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Centro Clinico Mediterraneo
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1700000
Country
Chile
Facility Name
Clinical Research Chile SpA
City
Valdivia
State/Province
Los Ríos
ZIP/Postal Code
5110683
Country
Chile
Facility Name
Centro de Investigaciones Clínicas Vina del Mar
City
Valparaíso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Fakultni nemocnice Ostrava- Interni a Kardiologicka Klinika, Oddeleni gastroenterologie, hepatologie a pankreatologie
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Aalborg Universitetshospital, Ambulatoriet for Medicinske Mave-Tarm Sygdomme
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Frankfurt. Medizinische Klinik I
City
Frankfurt am main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Ifi-Medizin GmbH
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis
City
Herne
ZIP/Postal Code
44623
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Ippokrateio General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Liver Unit
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Liver Disease Center, Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Institute for Digestive Tract & Liver Disease
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
ASST di Monza
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara
City
Bologna
ZIP/Postal Code
41126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliera Universita Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Inje University Busan Paik Hospital
City
Busan
State/Province
Busan Gwangyeogsi
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon-si
State/Province
Gyeonggido
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Soeul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Consultorio Medico - Distrito Federal
City
Ciudad de Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
City
Metepec
ZIP/Postal Code
52140
Country
Mexico
Facility Name
Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc
City
Mexico City
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio González
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Gastroenterology, Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Gastroenterology Research Unit Dunedin Hospital
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Uniwersyteckie Centrum Kliniczne Im.
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
ID Clinic Akradiusz Pisula
City
Mysłowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
State budget institution of healthcare of Moscow city "Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov" of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Clinic of High Medical Technologies n.a. N.I. Pirogov
City
Saint Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
LLC Medical Company "Hepatolog"
City
Samara
ZIP/Postal Code
443045
Country
Russian Federation
Facility Name
Stavropol state medical university
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Hospital Universitario German Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Margues de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
State/Province
Malaga
ZIP/Postal Code
2910
Country
Spain
Facility Name
Hospital Universitario 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
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
University of Zurich, Gastroenterology and Hepatology
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Ankara Gazi University Faculty of Medicine Hospital
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Ankara Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Bezmi Alem University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Ege University Medical Faculty
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Medical Center OK!Clinic+LLC International Institute of Clinical Research
City
Kyiv
ZIP/Postal Code
0291
Country
Ukraine
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
P06 3LY
Country
United Kingdom
Facility Name
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 1RF
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Gemini Clinical Trial Unit
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX4 2LL
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust, Heritage Building (Queen Elizabeth Hospital)
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
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