Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
NCT ID: NCT03439254
Last Updated: 2023-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
919 participants
INTERVENTIONAL
2017-08-30
2022-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Obeticholic Acid (OCA) 10 mg
10 mg OCA for up to 18 months
Obeticholic acid (10 mg)
Tablets administered orally once daily.
Obeticholic Acid (OCA) 10 mg to 25 mg
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
Obeticholic acid (10 mg to 25 mg)
Tablets administered orally once daily.
Placebo
Placebo for up to 18 months
Placebo
Tablets administered orally once daily.
Interventions
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Obeticholic acid (10 mg)
Tablets administered orally once daily.
Obeticholic acid (10 mg to 25 mg)
Tablets administered orally once daily.
Placebo
Tablets administered orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Intercept Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Objective GI d/b/a North Alabama GI Research Center
Madison, Alabama, United States
Arizona Liver Health
Chandler, Arizona, United States
Arizona Liver Health
Glendale, Arizona, United States
The Institute for Liver Health
Tucson, Arizona, United States
Liver Wellness Center
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Hope Clinical Research
Canoga Park, California, United States
University of California, San Francisco-Fresno
Fresno, California, United States
Scripps Whittier Diabetes Institute
La Jolla, California, United States
eStudySite
La Mesa, California, United States
Keck Hospital of USC
Los Angeles, California, United States
Cedars-Sinani Medical Center
Los Angeles, California, United States
Palmtree Clinical Research, INC.
Palm Springs, California, United States
Stanford University Medical Center
Palo Alto, California, United States
California Liver Research Institute
Pasadena, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Denver and Hospital
Aurora, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States
Hi Tech and Global Research LLC
Coral Gables, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
UF Health Jacksonville-Gastroenterology Emerson
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
Guardian Angel Research Center, INC
Tampa, Florida, United States
Florida Medical Clinic, P.A
Zephyrhills, Florida, United States
Summit Clinical Research, LLC
Athens, Georgia, United States
The Emory Clinic (TEC)
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Aquiant Research
New Albany, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas Medical Clinic
Topeka, Kansas, United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
Delta Research Partners, LLC
Monroe, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
UMass Memorial Health Care
Worcester, Massachusetts, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, United States
Southern Therapy and Advanced Research (STAR) LLC
Jackson, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
CHI Health Alegent Creighton Clinic
Omaha, Nebraska, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Amici GI-LLC
Martinsville, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
University at Buffalo, Clinical and Translational Research Center
Buffalo, New York, United States
Ichan School of Medicine at Mount Sinai Beth Israel
New York, New York, United States
NYU Langone Health
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill, School of Medicine
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolinas Center for Liver Disease/Carolinas HealthCare System
Huntersville, North Carolina, United States
Carolinas Health Care System Center for Liver Disease
Huntersville, North Carolina, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States
The Pennsylvania State University and the Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Einstein Healthcare Network
Philadelphia, Pennsylvania, United States
UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, United States
SCTR Research Nexus
Charleston, South Carolina, United States
Rapid City Medical Center LLP
Rapid City, South Dakota, United States
Gastro One
Germantown, Tennessee, United States
Associates in Gastroenterology, PLC
Hermitage, Tennessee, United States
Johnson City Medical Center
Johnson City, Tennessee, United States
Methodist Healthcare University Hospital
Memphis, Tennessee, United States
Quaility Medical Research, PLLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center - Digestive Disease Center
Nashville, Tennessee, United States
Texas Clinical Research Institute LLC
Arlington, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Liver Center of Texas
Dallas, Texas, United States
Texas Digestive Disease Consultants
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
Baylor Scott and White All Saints Medical Center
Fort Worth, Texas, United States
Texas Digestive Disease Consultants
Fort Worth, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
The University of Texas Medical School at Houston
Houston, Texas, United States
Centex Studies, Inc.
McAllen, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Texas Digestive Disease Consultants
San Marcos, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours
Richmond, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, United States
Virginia Mason - Seattle Medical Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Nepean Blue Mountains Local Health District, Nepean Hospital
Kingswood, New South Wales, Australia
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary, Alberta, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Kent Place
Lindsay, Ontario, Canada
London Health Sciences Centre-University Hospital
London, Ontario, Canada
Office of Dr. Gauthier
North Bay, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Clinique de medecine Urbaine du Quartier Latin
Montreal, Quebec, Canada
Chronic Viral Illness/McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
CHU Amiens Picardie
Amiens, , France
Centre Hospitalier Universitaire d'Angers
Angers, , France
Hôpital Beaujon- Service d'Hepatologie
Clichy, , France
Center Hospitalier Universitaire Grenoble Alpes
La Tronche, , France
Hôpital de la Croix Rousse
Lyon, , France
CHU de Nice, Hôpital de l'Archet 2
Nice, , France
Hôpital Pitié-Salpêtrierè
Paris, , France
CHU de Rouen-Centre Hospitalier Universitaire
Rouen, , France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, , France
Hôpital Hautepierre
Strasbourg, , France
Hôpital Purpan
Toulouse, , France
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
Hôpital Paul Brousse
Villejuif, , France
Univeritätsklinkum Würzburg
Würzburg, Bavaria, Germany
Teuber Consulting & Research UG
Frankfurt am Main, Hesse, Germany
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
EUGASTRO GmbH
Leipzig, Saxony, Germany
Universitätsklinikum Leipzig AöR
Leipzig, Saxony, Germany
Gastroenterologisch-Hepatologisches Zentrum Kiel
Kiel, Schleswig-Holstein, Germany
Charité - Universitätsmedzin Berlin
Berlin, , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Synexus Magyarország Kft. Budapest
Budapest, , Hungary
Synexus Magyarorszag Kft. Debrecen A.S.
Debrecen, , Hungary
Synexus Magyarorszag Kft. Gyula DRS
Gyula, , Hungary
Middlemore Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Public Hospital
Dunedin, , New Zealand
Wellington Regional Hospital
Wellington, , New Zealand
Synexus Polska Sp. z o.o., Oddział w Częstochowie
Częstochowa, , Poland
Synexus Polska Sp. z.o.o., Oddział w Gdańsku
Gdansk, , Poland
Synexus Polska Sp. Z.o.o., Oddział w Gdyni
Gdynia, , Poland
Synexus Polska Sp. z o.o., Oddział w Katowicach
Katowice, , Poland
Synexus Polska Sp. z o.o., Oddział w Łodzi
Lodz, , Poland
Synexus Polska Sp. z o.o., Oddział w Poznaniu
Poznan, , Poland
Synexus Polska Sp. z o.o., Oddział w Warszawie
Warsaw, , Poland
Synexus Polska Sp. z o.o., Oddział w Wrocławiu
Wroclaw, , Poland
Latin Clinical Trial Center
San Juan, , Puerto Rico
Fundación de Investigación de Diego
San Juan, , Puerto Rico
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politécnic La Fe
Valencia, , Spain
Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department
Kyiv, , Ukraine
Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department
Kyiv, , Ukraine
Derby Teaching Hospitals NHS Foundation Trust
Derby, Derbyshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom
Royal Free Hospital NHS Foundation Trust
London, England, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
London, England, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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747-304
Identifier Type: -
Identifier Source: org_study_id
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