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Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

Primary Purpose

Compensated Cirrhosis, Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Obeticholic acid (10 mg)
Obeticholic acid (10 mg to 25 mg)
Placebo
Sponsored by
Intercept Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compensated Cirrhosis focused on measuring Compensated Cirrhosis, Nonalcoholic Steatohepatitis, Fatty Liver Disease, NASH

Eligibility Criteria

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

Key inclusion criteria:

1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading

Key exclusion criteria:

  1. Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding
  2. Current or past history of CP score ≥7 points
  3. Model for End-stage Liver Disease (MELD) score > 12
  4. ALT ≥ 5 X ULN
  5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method
  6. Hemoglobin A1c (HbA1c) ≥ 9.5 %
  7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
  8. History of liver transplant, or current placement on a liver transplant list

Sites / Locations

  • Digestive Health Specialists of the Southeast
  • Objective GI d/b/a North Alabama GI Research Center
  • Arizona Liver Health
  • Arizona Liver Health
  • The Institute for Liver Health
  • Liver Wellness Center
  • Arkansas Gastroenterology
  • Hope Clinical Research
  • University of California, San Francisco-Fresno
  • Scripps Whittier Diabetes Institute
  • eStudySite
  • Keck Hospital of USC
  • Cedars-Sinani Medical Center
  • Palmtree Clinical Research, INC.
  • Stanford University Medical Center
  • California Liver Research Institute
  • Inland Empire Liver Foundation
  • University of California, Davis Medical Center
  • Kaiser Permanente Sacramento Medical Center
  • University of California, San Francisco
  • University of Colorado Denver and Hospital
  • Peak Gastroenterology Associates
  • South Denver Gastroenterology, PC
  • Innovative Medical Research of South Florida, Inc.
  • Hi Tech and Global Research LLC
  • Nature Coast Clinical Research
  • UF Health Jacksonville-Gastroenterology Emerson
  • Mayo Clinic Florida
  • Schiff Center for Liver Diseases/University of Miami
  • Sensible Healthcare, LLC
  • Innovation Medical Research Center
  • Gastroenterology Associates of Pensacola, PA
  • Tampa General Medical Group
  • Guardian Angel Research Center, INC
  • Florida Medical Clinic, P.A
  • Summit Clinical Research, LLC
  • The Emory Clinic (TEC)
  • Gastrointestinal Specialists of Georgia
  • Grand Teton Research Group, PLLC
  • Rush University Medical Center
  • Loyola University Medical Center
  • Aquiant Research
  • University of Kansas Medical Center
  • Kansas Medical Clinic
  • University of Louisville, Clinical Trials Unit
  • Tandem Clinical Research, LLC
  • Delta Research Partners, LLC
  • Tulane University Health Sciences Center
  • Louisiana Research Center
  • Mercy Medical Center
  • Walter Reed National Military Medical Center
  • Massachusetts General Hospital
  • Lahey Hospital & Medical Center
  • UMass Memorial Health Care
  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
  • Huron Gastroenterology Associates
  • Minnesota Gastroenterology, P.A.
  • Southern Therapy and Advanced Research (STAR) LLC
  • University of Mississippi Medical Center
  • Kansas City Research Institute
  • Washington University School of Medicine
  • CHI Health Alegent Creighton Clinic
  • Sierra Clinical Research
  • Amici GI-LLC
  • Rutgers New Jersey Medical School
  • Montefiore Medical Center
  • University at Buffalo, Clinical and Translational Research Center
  • Ichan School of Medicine at Mount Sinai Beth Israel
  • NYU Langone Health
  • Weill Cornell Medical College
  • University of Rochester Medical Center
  • Asheville Gastroenterology Associates, P.A.
  • University of North Carolina at Chapel Hill, School of Medicine
  • Charlotte Gastroenterology & Hepatology, PLLC
  • Duke University Medical Center
  • Carolinas Center for Liver Disease/Carolinas HealthCare System
  • Carolinas Health Care System Center for Liver Disease
  • Diabetes & Endocrinology Consultants, PC
  • Trial Management Associates, LLC
  • Dayton Gastroenterology, Inc.
  • The Ohio State University Wexner Medical Center
  • Northeast Clinical Research Center, LLC
  • The Pennsylvania State University and the Milton S. Hershey Medical Center
  • Thomas Jefferson University
  • Einstein Healthcare Network
  • UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
  • University Gastroenterology
  • Ralph H. Johnson Veterans Affairs Medical Center
  • SCTR Research Nexus
  • Rapid City Medical Center LLP
  • Gastro One
  • Associates in Gastroenterology, PLC
  • Johnson City Medical Center
  • Methodist Healthcare University Hospital
  • Quaility Medical Research, PLLC
  • Vanderbilt University Medical Center - Digestive Disease Center
  • Texas Clinical Research Institute LLC
  • The Liver Institute at Methodist Dallas Medical Center
  • Liver Center of Texas
  • Texas Digestive Disease Consultants
  • UT Southwestern Medical Center
  • San Antonio Military Medical Center
  • Baylor Scott and White All Saints Medical Center
  • Texas Digestive Disease Consultants
  • Baylor College of Medicine - Advanced Liver Therapies
  • The University of Texas Medical School at Houston
  • Centex Studies, Inc.
  • American Research Corporation
  • Clinical Trials of Texas, Inc.
  • Texas Digestive Disease Consultants
  • The University of Vermont Medical Center
  • Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads
  • Digestive and Liver Disease Specialists
  • Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours
  • McGuire VA Medical Center
  • Virginia Commonwealth University
  • Gastroenterology Consultants of Southwest Virginia
  • Virginia Mason - Seattle Medical Center
  • Harborview Medical Center
  • University of Washington Medical Center
  • Nepean Blue Mountains Local Health District, Nepean Hospital
  • Mater Misericordiae Limited
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • St Vincent's Hospital
  • Austin Health
  • Royal Melbourne Hospital
  • University of Calgary Liver Unit (Heritage Medical Research Clinic)
  • (G.I.R.I.) GI Research Institute
  • Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
  • Kent Place
  • London Health Sciences Centre-University Hospital
  • Office of Dr. Gauthier
  • Toronto Liver Centre
  • Chronic Viral Illness/McGill University Health Centre (MUHC)
  • Clinique de medecine Urbaine du Quartier Latin
  • CHU Amiens Picardie
  • Centre Hospitalier Universitaire d'Angers
  • Hôpital Beaujon- Service d'Hepatologie
  • Center Hospitalier Universitaire Grenoble Alpes
  • Hôpital de la Croix Rousse
  • CHU de Nice, Hôpital de l'Archet 2
  • Hôpital Pitié-Salpêtrierè
  • CHU de Rouen-Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire de Strasbourg
  • Hôpital Hautepierre
  • Hôpital Purpan
  • CHRU de Nancy - Hôpitaux de Brabois
  • Hôpital Paul Brousse
  • Univeritätsklinkum Würzburg
  • Teuber Consulting & Research UG
  • Universitätsmedizin Mainz
  • EUGASTRO GmbH
  • Universitätsklinikum Leipzig AöR
  • Gastroenterologisch-Hepatologisches Zentrum Kiel
  • Charité - Universitätsmedzin Berlin
  • Universitätsklinikum Hamburg Eppendorf
  • Synexus Magyarország Kft. Budapest
  • Synexus Magyarorszag Kft. Debrecen A.S.
  • Synexus Magyarorszag Kft. Gyula DRS
  • Middlemore Hospital
  • Christchurch Hospital
  • Dunedin Public Hospital
  • Wellington Regional Hospital
  • Synexus Polska Sp. z o.o., Oddział w Częstochowie
  • Synexus Polska Sp. z.o.o., Oddział w Gdańsku
  • Synexus Polska Sp. Z.o.o., Oddział w Gdyni
  • Synexus Polska Sp. z o.o., Oddział w Katowicach
  • Synexus Polska Sp. z o.o., Oddział w Poznaniu
  • Synexus Polska Sp. z o.o., Oddział w Warszawie
  • Synexus Polska Sp. z o.o., Oddział w Wrocławiu
  • Synexus Polska Sp. z o.o., Oddział w Łodzi
  • Latin Clinical Trial Center
  • Fundación de Investigación de Diego
  • Hospital Clínic de Barcelona
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Virgen del Rocio
  • Hospital General Universitario de Valencia
  • Hospital Universitari i Politécnic La Fe
  • Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department
  • Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department
  • Derby Teaching Hospitals NHS Foundation Trust
  • University Hospitals Birmingham NHS Foundation Trust
  • Royal Free Hospital NHS Foundation Trust
  • King's College Hospital NHS Foundation Trust
  • Imperial College Healthcare NHS Trust, St Mary's Hospital
  • Nottingham University Hospitals NHS Trust
  • Derriford Hospital
  • Oxford University Hospitals NHS Foundation Trust
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Obeticholic Acid (OCA) 10 mg

Obeticholic Acid (OCA) 10 mg to 25 mg

Placebo

Arm Description

10 mg OCA for up to 18 months

10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study

Placebo for up to 18 months

Outcomes

Primary Outcome Measures

DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH)
Fibrosis stage was evaluated by NASH Clinical Research Network(CRN)Fibrosis Staging System with stages:0=no fibrosis;1=perisinusoidal/periportal;1A=mild,zone 3,perisinusoidal;1B=moderate,zone 3,perisinusoidal;1C=portal/periportal;2=perisinusoidal and portal/periportal;3=bridging fibrosis;4=cirrhosis.No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories.NAS is semiquantitative scoring system based on unweighted sum of:steatosis (0=<5% to 3=>66%),lobular inflammation(0=no foci to 3=>4 foci/200x),hepatocellular ballooning(0=none to 2=many cells/prominent ballooning)scores.Total scale range:0-12;0:no features of fatty liver disease and 12:highest degree of fatty liver disease.Higher scores:worse symptoms.Responders:did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment
OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM)
Non-invasive radiological methods to assess liver stiffness were conducted at selected study sites where the respective devices were available. These assessments were taken by vibration controlled transient elastography (TE) method using FibroScan®. Participant was included as a random effect and an unstructured covariance matrix was used assuming convergence could be attained. Baseline was defined as the last value collected prior to the first administration of the investigational product (IP). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
OLE Phase: Fibrosis-4 (FIB-4) at Baseline
FIB-4 was a noninvasive assessment of liver disease assessed by a combination of age, alanine aminotransferase (ALT) and platelet results. FIB-4 was the ratio of age in years and aminotransferase to platelet count. It was a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, ALT, Aspartate aminotransferase (AST) and age that was calculated using formula: FIB-4 = (Age [years] x AST [Units per Liter {U/L}]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of <1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. Higher ratio indicated worse condition. Baseline was defined as the last value collected prior to the first administration of the IP.
OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline
ELF was non-invasive panel of circulating fibrosis markers calculated from serum biomarkers. The markers of fibrosis comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP). Each of these markers was measured by an immunoassay and an ELF score was generated, from which a level of fibrosis severity could be determined. The ELF test was a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.; higher ELF scores were associated with worsening liver fibrosis. Baseline was defined as the last value collected prior to the first administration of the IP.
OLE Phase: Number of Participants Reporting All-cause Mortality
All-cause mortality is defined as death due to any cause. Number of participants reporting all-cause mortality is presented
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Ascites, Hepatocellular Carcinoma (HCC) and Non-liver Related Death
Adjudication was performed under the review of Hepatic Safety Adjudication Committee (HSAC) of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for the following is presented: Ascites (secondary to cirrhosis and requiring medical intervention), Hepatocellular carcinoma (HCC) and non-liver related death.
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Worsening of Child-Pugh Score
The Child-Pugh classification was a scoring system used for the classification of the severity of cirrhosis. It included three continuous variables (bilirubin, albumin, and international normalized ratio) and two discrete variables (ascites and encephalopathy). Each variable was scored 1-3 with 3 indicating most severe derangement. The determination of Child-Pugh score ranged from 5 to 15. The higher the score, the sicker the participant. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for worsening of Child-Pugh score is presented.
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Model for End-Stage Liver Disease (MELD) Score ≥15
MELD was a scoring system for assessing the severity of chronic liver disease and to assess prognosis and suitability for liver transplantation. It uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality. Higher scores indicated greater disease severity. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for MELD score ≥15 is presented.

Secondary Outcome Measures

DB Phase: Change From Baseline to Month 18 in LSM
Non-invasive radiological methods to assess liver stiffness were conducted at selected study sites where the respective devices were available. These assessments were taken by vibration controlled TE method using FibroScan®. Participant was included as a random effect and an unstructured covariance matrix was used assuming convergence could be attained. The principal comparison was at Month 18. Baseline was defined as the last value collected prior to the first administration of the IP. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
DB Phase: FIB-4 at Baseline
FIB-4 was a noninvasive assessment of liver disease assessed by a combination of age, ALT and platelet results. FIB-4 was the ratio of age in years and aminotransferase to platelet count. It was a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, ALT, AST and age that was calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of <1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. Higher ratio indicated worse condition. Baseline was defined as the last value collected prior to the first administration of the IP.
DB Phase: ELF at Baseline
ELF was non-invasive panel of circulating fibrosis markers calculated from serum biomarkers. The markers of fibrosis comprised HA, TIMP1 and PIIINP. Each of these markers was measured by an immunoassay and an ELF score was generated, from which a level of fibrosis severity could be determined. The ELF test was a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.; higher ELF scores were associated with worsening liver fibrosis. Baseline was defined as the last value collected prior to the first administration of the IP.

Full Information

First Posted
February 14, 2018
Last Updated
October 19, 2023
Sponsor
Intercept Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03439254
Brief Title
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Acronym
REVERSE
Official Title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
September 8, 2022 (Actual)
Study Completion Date
September 8, 2022 (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
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Keywords
Compensated Cirrhosis, Nonalcoholic Steatohepatitis, Fatty Liver Disease, NASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
919 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obeticholic Acid (OCA) 10 mg
Arm Type
Experimental
Arm Description
10 mg OCA for up to 18 months
Arm Title
Obeticholic Acid (OCA) 10 mg to 25 mg
Arm Type
Experimental
Arm Description
10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for up to 18 months
Intervention Type
Drug
Intervention Name(s)
Obeticholic acid (10 mg)
Other Intervention Name(s)
OCA, 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747
Intervention Description
Tablets administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Obeticholic acid (10 mg to 25 mg)
Other Intervention Name(s)
OCA, 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747
Intervention Description
Tablets administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets administered orally once daily.
Primary Outcome Measure Information:
Title
DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH)
Description
Fibrosis stage was evaluated by NASH Clinical Research Network(CRN)Fibrosis Staging System with stages:0=no fibrosis;1=perisinusoidal/periportal;1A=mild,zone 3,perisinusoidal;1B=moderate,zone 3,perisinusoidal;1C=portal/periportal;2=perisinusoidal and portal/periportal;3=bridging fibrosis;4=cirrhosis.No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories.NAS is semiquantitative scoring system based on unweighted sum of:steatosis (0=<5% to 3=>66%),lobular inflammation(0=no foci to 3=>4 foci/200x),hepatocellular ballooning(0=none to 2=many cells/prominent ballooning)scores.Total scale range:0-12;0:no features of fatty liver disease and 12:highest degree of fatty liver disease.Higher scores:worse symptoms.Responders:did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment
Time Frame
Up to 18 months
Title
OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time Frame
Up to 12 months
Title
OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM)
Description
Non-invasive radiological methods to assess liver stiffness were conducted at selected study sites where the respective devices were available. These assessments were taken by vibration controlled transient elastography (TE) method using FibroScan®. Participant was included as a random effect and an unstructured covariance matrix was used assuming convergence could be attained. Baseline was defined as the last value collected prior to the first administration of the investigational product (IP). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame
Baseline and up to Month 12
Title
OLE Phase: Fibrosis-4 (FIB-4) at Baseline
Description
FIB-4 was a noninvasive assessment of liver disease assessed by a combination of age, alanine aminotransferase (ALT) and platelet results. FIB-4 was the ratio of age in years and aminotransferase to platelet count. It was a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, ALT, Aspartate aminotransferase (AST) and age that was calculated using formula: FIB-4 = (Age [years] x AST [Units per Liter {U/L}]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of <1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. Higher ratio indicated worse condition. Baseline was defined as the last value collected prior to the first administration of the IP.
Time Frame
Baseline (Day 1)
Title
OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline
Description
ELF was non-invasive panel of circulating fibrosis markers calculated from serum biomarkers. The markers of fibrosis comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP). Each of these markers was measured by an immunoassay and an ELF score was generated, from which a level of fibrosis severity could be determined. The ELF test was a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.; higher ELF scores were associated with worsening liver fibrosis. Baseline was defined as the last value collected prior to the first administration of the IP.
Time Frame
Baseline (Day 1)
Title
OLE Phase: Number of Participants Reporting All-cause Mortality
Description
All-cause mortality is defined as death due to any cause. Number of participants reporting all-cause mortality is presented
Time Frame
Up to Month 12
Title
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Ascites, Hepatocellular Carcinoma (HCC) and Non-liver Related Death
Description
Adjudication was performed under the review of Hepatic Safety Adjudication Committee (HSAC) of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for the following is presented: Ascites (secondary to cirrhosis and requiring medical intervention), Hepatocellular carcinoma (HCC) and non-liver related death.
Time Frame
Up to 12 months
Title
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Worsening of Child-Pugh Score
Description
The Child-Pugh classification was a scoring system used for the classification of the severity of cirrhosis. It included three continuous variables (bilirubin, albumin, and international normalized ratio) and two discrete variables (ascites and encephalopathy). Each variable was scored 1-3 with 3 indicating most severe derangement. The determination of Child-Pugh score ranged from 5 to 15. The higher the score, the sicker the participant. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for worsening of Child-Pugh score is presented.
Time Frame
Up to 12 months
Title
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Model for End-Stage Liver Disease (MELD) Score ≥15
Description
MELD was a scoring system for assessing the severity of chronic liver disease and to assess prognosis and suitability for liver transplantation. It uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality. Higher scores indicated greater disease severity. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for MELD score ≥15 is presented.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
DB Phase: Change From Baseline to Month 18 in LSM
Description
Non-invasive radiological methods to assess liver stiffness were conducted at selected study sites where the respective devices were available. These assessments were taken by vibration controlled TE method using FibroScan®. Participant was included as a random effect and an unstructured covariance matrix was used assuming convergence could be attained. The principal comparison was at Month 18. Baseline was defined as the last value collected prior to the first administration of the IP. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame
Baseline and up to Month 18
Title
DB Phase: FIB-4 at Baseline
Description
FIB-4 was a noninvasive assessment of liver disease assessed by a combination of age, ALT and platelet results. FIB-4 was the ratio of age in years and aminotransferase to platelet count. It was a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, ALT, AST and age that was calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of <1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. Higher ratio indicated worse condition. Baseline was defined as the last value collected prior to the first administration of the IP.
Time Frame
Baseline (Day 1)
Title
DB Phase: ELF at Baseline
Description
ELF was non-invasive panel of circulating fibrosis markers calculated from serum biomarkers. The markers of fibrosis comprised HA, TIMP1 and PIIINP. Each of these markers was measured by an immunoassay and an ELF score was generated, from which a level of fibrosis severity could be determined. The ELF test was a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.; higher ELF scores were associated with worsening liver fibrosis. Baseline was defined as the last value collected prior to the first administration of the IP.
Time Frame
Baseline (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria: 1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading Key exclusion criteria: Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding Current or past history of CP score ≥7 points Model for End-stage Liver Disease (MELD) score > 12 ALT ≥ 5 X ULN Calculated creatinine clearance <60mL/min using Cockcroft-Gault method Hemoglobin A1c (HbA1c) ≥ 9.5 % Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC) History of liver transplant, or current placement on a liver transplant list
Facility Information:
Facility Name
Digestive Health Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Objective GI d/b/a North Alabama GI Research Center
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758
Country
United States
Facility Name
Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Liver Health
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
The Institute for Liver Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Liver Wellness Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
University of California, San Francisco-Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Scripps Whittier Diabetes Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinani Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Palmtree Clinical Research, INC.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
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 Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
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
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Hi Tech and Global Research LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
UF Health Jacksonville-Gastroenterology Emerson
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
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
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Innovation Medical Research Center
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Gastroenterology Associates of Pensacola, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Tampa General Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Guardian Angel Research Center, INC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Florida Medical Clinic, P.A
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Summit Clinical Research, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
The Emory Clinic (TEC)
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
Grand Teton Research Group, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Aquiant Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kansas Medical Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Louisville, Clinical Trials Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tandem Clinical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Delta Research Partners, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
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
Louisiana Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
UMass Memorial Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Huron Gastroenterology Associates
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
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) LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Mississippi Medical Center
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
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CHI Health Alegent Creighton Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Amici GI-LLC
City
Martinsville
State/Province
New Jersey
ZIP/Postal Code
08836
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University at Buffalo, Clinical and Translational Research Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Ichan School of Medicine at Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NYU Langone Health
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
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill, School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Gastroenterology & Hepatology, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolinas Center for Liver Disease/Carolinas HealthCare System
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Carolinas Health Care System Center for Liver Disease
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Diabetes & Endocrinology Consultants, PC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Dayton Gastroenterology, Inc.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
The Pennsylvania State University and the Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Ralph H. Johnson Veterans Affairs Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
SCTR Research Nexus
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Rapid City Medical Center LLP
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Associates in Gastroenterology, PLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Johnson City Medical Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Methodist Healthcare University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Quaility Medical Research, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Vanderbilt University Medical Center - Digestive Disease Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Clinical Research Institute LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
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
Liver Center of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
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
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Baylor Scott and White All Saints Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Digestive Disease Consultants
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
The University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centex Studies, Inc.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Gastroenterology Consultants of Southwest Virginia
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Virginia Mason - Seattle Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Nepean Blue Mountains Local Health District, Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Mater Misericordiae Limited
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
University of Calgary Liver Unit (Heritage Medical Research Clinic)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2M 4Z6
Country
Canada
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Kent Place
City
Lindsay
State/Province
Ontario
ZIP/Postal Code
K9V 5G6
Country
Canada
Facility Name
London Health Sciences Centre-University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Office of Dr. Gauthier
City
North Bay
State/Province
Ontario
ZIP/Postal Code
PIB 2H3
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
Chronic Viral Illness/McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3JI
Country
Canada
Facility Name
Clinique de medecine Urbaine du Quartier Latin
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hôpital Beaujon- Service d'Hepatologie
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Center Hospitalier Universitaire Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
CHU de Nice, Hôpital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Pitié-Salpêtrierè
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de Rouen-Centre Hospitalier Universitaire
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Hospitalier Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU de Nancy - Hôpitaux de Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Univeritätsklinkum Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Teuber Consulting & Research UG
City
Frankfurt am main
State/Province
Hessen
ZIP/Postal Code
60594
Country
Germany
Facility Name
Universitätsmedizin Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Gastroenterologisch-Hepatologisches Zentrum Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24146
Country
Germany
Facility Name
Charité - Universitätsmedzin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Synexus Magyarország Kft. Budapest
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Synexus Magyarorszag Kft. Debrecen A.S.
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Synexus Magyarorszag Kft. Gyula DRS
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Public Hospital
City
Dunedin
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Wellington Regional Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Synexus Polska Sp. z o.o., Oddział w Częstochowie
City
Częstochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Synexus Polska Sp. z.o.o., Oddział w Gdańsku
City
Gdańsk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus Polska Sp. Z.o.o., Oddział w Gdyni
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Synexus Polska Sp. z o.o., Oddział w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Synexus Polska Sp. z o.o., Oddział w Poznaniu
City
Poznań
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Synexus Polska Sp. z o.o., Oddział w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Synexus Polska Sp. z o.o., Oddział w Wrocławiu
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Synexus Polska Sp. z o.o., Oddział w Łodzi
City
Łódź
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Fundación de Investigación de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitari i Politécnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Derby Teaching Hospitals NHS Foundation Trust
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Royal Free Hospital NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust, St Mary's Hospital
City
London
State/Province
England
ZIP/Postal Code
W2 INY
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

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