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AzTrials

Compensated CirrhosisPhase 3REVERSENCT03439254

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

A Phase 3 study testing Obeticholic acid (10 mg) and Obeticholic acid (10 mg to 25 mg) in people with Compensated Cirrhosis and Nonalcoholic Steatohepatitis, run by Intercept Pharmaceuticals at 192 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Obeticholic acid (10 mg) and Obeticholic acid (10 mg to 25 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
919 participants
Where
192 sitesin 12 countries
Study dates
30 Aug 2017to 8 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

192 sites in 12 countries.

192 sites in 12 countries

United States120 sites

  • Texas Clinical Research Institute LLC

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Summit Clinical Research, LLC

    Athens, Georgia, 30607

  • The Emory Clinic (TEC)

    Atlanta, Georgia, 30322

  • University of Colorado Denver and Hospital

    Aurora, Colorado, 80045

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida, 33180

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Dayton Gastroenterology, Inc.

    Beavercreek, Ohio, 45440

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University at Buffalo, Clinical and Translational Research Center

    Buffalo, New York, 14203

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Arizona Liver Health

    Chandler, Arizona, 85224

  • University of North Carolina at Chapel Hill, School of Medicine

    Chapel Hill, North Carolina, 27599

  • Ralph H. Johnson Veterans Affairs Medical Center

    Charleston, South Carolina, 29401

  • SCTR Research Nexus

    Charleston, South Carolina, 29425

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Hi Tech and Global Research LLC

    Coral Gables, Florida, 33134

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Liver Center of Texas

    Dallas, Texas, 75234

  • Texas Digestive Disease Consultants

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • South Denver Gastroenterology, PC

    Englewood, Colorado, 80113

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • Baylor Scott and White All Saints Medical Center

    Fort Worth, Texas, 76104

  • Texas Digestive Disease Consultants

    Fort Worth, Texas, 76104

  • University of California, San Francisco-Fresno

    Fresno, California, 93701

  • Gastro One

    Germantown, Tennessee, 38138

  • Arizona Liver Health

    Glendale, Arizona, 85306

  • Associates in Gastroenterology, PLC

    Hermitage, Tennessee, 37076

  • The Pennsylvania State University and the Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030

  • The University of Texas Medical School at Houston

    Houston, Texas, 77030

  • Carolinas Center for Liver Disease/Carolinas HealthCare System

    Huntersville, North Carolina, 28078

  • Carolinas Health Care System Center for Liver Disease

    Huntersville, North Carolina, 28078

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Southern Therapy and Advanced Research (STAR) LLC

    Jackson, Mississippi, 39216

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • UF Health Jacksonville-Gastroenterology Emerson

    Jacksonville, Florida, 32207

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Johnson City Medical Center

    Johnson City, Tennessee, 37604

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037

  • eStudySite

    La Mesa, California, 91942

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Liver Wellness Center

    Little Rock, Arkansas, 72205

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • Cedars-Sinani Medical Center

    Los Angeles, California, 90048

  • University of Louisville, Clinical Trials Unit

    Louisville, Kentucky, 40202

  • Objective GI d/b/a North Alabama GI Research Center

    Madison, Alabama, 35758

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072

  • Amici GI-LLC

    Martinsville, New Jersey, 08836

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Centex Studies, Inc.

    McAllen, Texas, 78504

  • Methodist Healthcare University Hospital

    Memphis, Tennessee, 38104

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136

  • Delta Research Partners, LLC

    Monroe, Louisiana, 71201

  • Diabetes & Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

  • Quaility Medical Research, PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center - Digestive Disease Center

    Nashville, Tennessee, 37232

  • Aquiant Research

    New Albany, Indiana, 47150

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ichan School of Medicine at Mount Sinai Beth Israel

    New York, New York, 10003

  • NYU Langone Health

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia, 23602

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • CHI Health Alegent Creighton Clinic

    Omaha, Nebraska, 68124

  • Palmtree Clinical Research, INC.

    Palm Springs, California, 92262

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • California Liver Research Institute

    Pasadena, California, 91105

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

  • UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute

    Pittsburgh, Pennsylvania, 15213

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Rapid City Medical Center LLP

    Rapid City, South Dakota, 57701

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours

    Richmond, Virginia, 23226

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia, 24014

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • Minnesota Gastroenterology, P.A.

    Saint Paul, Minnesota, 55114

  • American Research Corporation

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • University of California, San Francisco

    San Francisco, California, 94143

  • Texas Digestive Disease Consultants

    San Marcos, Texas, 78666

  • Virginia Mason - Seattle Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Louisiana Research Center

    Shreveport, Louisiana, 71105

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Tampa General Medical Group

    Tampa, Florida, 33606

  • Guardian Angel Research Center, INC

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Kansas Medical Clinic

    Topeka, Kansas, 66606

  • The Institute for Liver Health

    Tucson, Arizona, 85712

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • UMass Memorial Health Care

    Worcester, Massachusetts, 01655

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, P.A

    Zephyrhills, Florida, 33542

Other trials in United States

France13 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933

  • Hôpital Beaujon- Service d'Hepatologie

    Clichy, 92110

  • Center Hospitalier Universitaire Grenoble Alpes

    La Tronche, 38700

  • Hôpital de la Croix Rousse

    Lyon, 69317

  • CHU de Nice, Hôpital de l'Archet 2

    Nice, 06202

  • Hôpital Pitié-Salpêtrierè

    Paris, 75651

  • CHU de Rouen-Centre Hospitalier Universitaire

    Rouen, 76031

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg, 67000

  • Hôpital Hautepierre

    Strasbourg, 67200

  • Hôpital Purpan

    Toulouse, 31059

  • CHRU de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Hôpital Paul Brousse

    Villejuif, 94800

Other trials in France

Canada9 sites

  • University of Calgary Liver Unit (Heritage Medical Research Clinic)

    Calgary, Alberta, T2M 4Z6

  • Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • Kent Place

    Lindsay, Ontario, K9V 5G6

  • London Health Sciences Centre-University Hospital

    London, Ontario, N6A 5A5

  • Clinique de medecine Urbaine du Quartier Latin

    Montreal, Quebec, H2L 4E9

  • Chronic Viral Illness/McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3JI

  • Office of Dr. Gauthier

    North Bay, Ontario, PIB 2H3

  • Toronto Liver Centre

    Toronto, Ontario, V5Z 1H2

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

United Kingdom9 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, England, B15 2TH

  • Derby Teaching Hospitals NHS Foundation Trust

    Derby, Derbyshire, DE22 3NE

  • Royal Free Hospital NHS Foundation Trust

    London, England, NW3 2QG

  • King's College Hospital NHS Foundation Trust

    London, England, SE5 9RS

  • Imperial College Healthcare NHS Trust, St Mary's Hospital

    London, England, W2 INY

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Nottingham University Hospitals NHS Trust

    Nottingham, England, NG7 2UH

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU

  • Derriford Hospital

    Plymouth, England, PL6 8DH

Other trials in United Kingdom

Germany8 sites

  • Charité - Universitätsmedzin Berlin

    Berlin, 13353

  • Teuber Consulting & Research UG

    Frankfurt am Main, Hesse, 60594

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Gastroenterologisch-Hepatologisches Zentrum Kiel

    Kiel, Schleswig-Holstein, 24146

  • EUGASTRO GmbH

    Leipzig, Saxony, 04103

  • Universitätsklinikum Leipzig AöR

    Leipzig, Saxony, 04103

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Univeritätsklinkum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Poland8 sites

  • Synexus Polska Sp. z o.o., Oddział w Częstochowie

    Częstochowa, 42-200

  • Synexus Polska Sp. z.o.o., Oddział w Gdańsku

    Gdansk, 80-382

  • Synexus Polska Sp. Z.o.o., Oddział w Gdyni

    Gdynia, 81-537

  • Synexus Polska Sp. z o.o., Oddział w Katowicach

    Katowice, 40-040

  • Synexus Polska Sp. z o.o., Oddział w Łodzi

    Lodz, 90-127

  • Synexus Polska Sp. z o.o., Oddział w Poznaniu

    Poznan, 60-702

  • Synexus Polska Sp. z o.o., Oddział w Warszawie

    Warsaw, 01-192

  • Synexus Polska Sp. z o.o., Oddział w Wrocławiu

    Wroclaw, 50-381

Other trials in Poland

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Austin Health

    Heidelberg, Victoria, 3084

  • Nepean Blue Mountains Local Health District, Nepean Hospital

    Kingswood, New South Wales, 2747

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mater Misericordiae Limited

    South Brisbane, Queensland, 4101

Other trials in Australia

Spain7 sites

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politécnic La Fe

    Valencia, 46026

Other trials in Spain

New Zealand4 sites

  • Middlemore Hospital

    Auckland, 2025

  • Christchurch Hospital

    Christchurch, 8011

  • Dunedin Public Hospital

    Dunedin, 6021

  • Wellington Regional Hospital

    Wellington, 6021

Other trials in New Zealand

Hungary3 sites

  • Synexus Magyarország Kft. Budapest

    Budapest, 1036

  • Synexus Magyarorszag Kft. Debrecen A.S.

    Debrecen, 4025

  • Synexus Magyarorszag Kft. Gyula DRS

    Gyula, 5700

Other trials in Hungary

Puerto Rico2 sites

  • Latin Clinical Trial Center

    San Juan, 00909

  • Fundación de Investigación de Diego

    San Juan, 00927

Other trials in Puerto Rico

Ukraine2 sites

  • Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department

    Kyiv, 03037

  • Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department

    Kyiv, 03049

Other trials in Ukraine

About this study

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

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.

Being tested
Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg), Placebo
Keywords
Compensated Cirrhosis, Nonalcoholic Steatohepatitis, Fatty Liver Disease, NASH
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Obeticholic acid (10 mg)Drug

    Also called OCA, 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747

    Tablets administered orally once daily.

  • Obeticholic acid (10 mg to 25 mg)Drug

    Also called OCA, 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747

    Tablets administered orally once daily.

  • PlaceboDrug

    Tablets administered orally once daily.

Study groups in NCT03439254
Study groupRoleWhat they receive
Obeticholic Acid (OCA) 10 mgExperimental10 mg OCA for up to 18 months
Receives: Drug: Obeticholic acid (10 mg)
Obeticholic Acid (OCA) 10 mg to 25 mgExperimental10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study
Receives: Drug: Obeticholic acid (10 mg to 25 mg)
PlaceboPlacebo comparatorPlacebo for up to 18 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 18 months

  2. 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.

    Measured: Up to 12 months

  3. 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.

    Measured: Baseline and up to Month 12

  4. 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.

    Measured: Baseline (Day 1)

  5. 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.

    Measured: Baseline (Day 1)

  6. 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

    Measured: Up to Month 12

  7. 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.

    Measured: Up to 12 months

  8. 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.

    Measured: Up to 12 months

  9. 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.

    Measured: Up to 12 months

Secondary outcomes (3)

  1. 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.

    Measured: Baseline and up to Month 18

  2. 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.

    Measured: Baseline (Day 1)

  3. 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.

    Measured: Baseline (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2018
  2. Study start30 Aug 2017
  3. Primary completion8 Sep 2022
  4. Study completion8 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
919 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03439254
Sponsor's protocol ID
747-304
Acronym
REVERSE
Status last verified
Oct 2023
First submitted
14 Feb 2018
Last updated
23 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Obeticholic acid (10 mg) and Obeticholic acid (10 mg to 25 mg) in people with Compensated Cirrhosis and Nonalcoholic Steatohepatitis, run by Intercept Pharmaceuticals at 192 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States, France, Canada, United Kingdom, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) (time frame: Up to 18 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03439254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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