919
Participants
Start Date
August 30, 2017
Primary Completion Date
September 8, 2022
Study Completion Date
September 8, 2022
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.
Synexus Magyarország Kft. Budapest, Budapest
Middlemore Hospital, Auckland
Nepean Blue Mountains Local Health District, Nepean Hospital, Kingswood
Royal Melbourne Hospital, Parkville
St Vincent's Hospital, Fitzroy
Austin Health, Heidelberg
Synexus Magyarorszag Kft. Debrecen A.S., Debrecen
Mater Misericordiae Limited, South Brisbane
Royal Adelaide Hospital, Adelaide
Flinders Medical Centre, Bedford Park
Synexus Magyarorszag Kft. Gyula DRS, Gyula
Dunedin Public Hospital, Dunedin
Wellington Regional Hospital, Wellington
Christchurch Hospital, Christchurch
Ichan School of Medicine at Mount Sinai Beth Israel, New York
NYU Langone Health, New York
Weill Cornell Medical College, New York
Montefiore Medical Center, The Bronx
Charité - Universitätsmedzin Berlin, Berlin
University at Buffalo, Clinical and Translational Research Center, Buffalo
University of Rochester Medical Center, Rochester
UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute, Pittsburgh
The Pennsylvania State University and the Milton S. Hershey Medical Center, Hershey
Northeast Clinical Research Center, LLC, Bethlehem
Thomas Jefferson University, Philadelphia
Einstein Healthcare Network, Philadelphia
Universitätsklinikum Hamburg Eppendorf, Hamburg
Walter Reed National Military Medical Center, Bethesda
Mercy Medical Center, Baltimore
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours, Richmond
McGuire VA Medical Center, Richmond
Virginia Commonwealth University, Richmond
Digestive and Liver Disease Specialists, Norfolk
Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads, Newport News
Gastroenterology Consultants of Southwest Virginia, Roanoke
Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel
University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill
Duke University Medical Center, Durham
Hospital Universitario La Paz, Madrid
Carolinas Center for Liver Disease/Carolinas HealthCare System, Huntersville
Carolinas Health Care System Center for Liver Disease, Huntersville
Charlotte Gastroenterology & Hepatology, PLLC, Charlotte
Hospital Universitario Puerta de Hierro Majadahonda, Madrid
Trial Management Associates, LLC, Wilmington
Diabetes & Endocrinology Consultants, PC, Morehead City
Asheville Gastroenterology Associates, P.A., Asheville
Ralph H. Johnson Veterans Affairs Medical Center, Charleston
SCTR Research Nexus, Charleston
Gastrointestinal Specialists of Georgia, Marietta
The Emory Clinic (TEC), Atlanta
Summit Clinical Research, LLC, Athens
Hôpital Purpan, Toulouse
UF Health Jacksonville-Gastroenterology Emerson, Jacksonville
Mayo Clinic Florida, Jacksonville
Gastroenterology Associates of Pensacola, PA, Pensacola
Hi Tech and Global Research LLC, Coral Gables
Schiff Center for Liver Diseases/University of Miami, Miami
Innovation Medical Research Center, Palmetto Bay
Innovative Medical Research of South Florida, Inc., Aventura
Florida Medical Clinic, P.A, Zephyrhills
Tampa General Medical Group, Tampa
Guardian Angel Research Center, INC, Tampa
Nature Coast Clinical Research, Inverness
Sensible Healthcare, LLC, Ocoee
Objective GI d/b/a North Alabama GI Research Center, Madison
Digestive Health Specialists of the Southeast, Dothan
Associates in Gastroenterology, PLC, Hermitage
Quaility Medical Research, PLLC, Nashville
Vanderbilt University Medical Center - Digestive Disease Center, Nashville
Johnson City Medical Center, Johnson City
Methodist Healthcare University Hospital, Memphis
Gastro One, Germantown
Center Hospitalier Universitaire Grenoble Alpes, La Tronche
Hospital Universitario Marqués de Valdecilla, Santander
Southern Therapy and Advanced Research (STAR) LLC, Jackson
University of Mississippi Medical Center, Jackson
University of Louisville, Clinical Trials Unit, Louisville
Hospital Universitario Virgen del Rocio, Seville
The Ohio State University Wexner Medical Center, Columbus
Dayton Gastroenterology, Inc., Beavercreek
Hospital General Universitario de Valencia, Valencia
Hospital Universitari i Politécnic La Fe, Valencia
Aquiant Research, New Albany
Huron Gastroenterology Associates, Ypsilanti
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center, Wyoming
Centre Hospitalier Universitaire d'Angers, Angers
CHRU de Nancy - Hôpitaux de Brabois, Vandœuvre-lès-Nancy
Minnesota Gastroenterology, P.A., Saint Paul
Universitätsmedizin Mainz, Mainz
Rapid City Medical Center LLP, Rapid City
Loyola University Medical Center, Maywood
Teuber Consulting & Research UG, Frankfurt am Main
Rush University Medical Center, Chicago
Washington University School of Medicine, St Louis
Kansas City Research Institute, Kansas City
University of Kansas Medical Center, Kansas City
Kansas Medical Clinic, Topeka
Centre Hospitalier Universitaire de Strasbourg, Strasbourg
Hôpital Hautepierre, Strasbourg
CHI Health Alegent Creighton Clinic, Omaha
Hôpital de la Croix Rousse, Lyon
Tandem Clinical Research, LLC, Marrero
Tulane University Health Sciences Center, New Orleans
Louisiana Research Center, Shreveport
Delta Research Partners, LLC, Monroe
Arkansas Gastroenterology, North Little Rock
Liver Wellness Center, Little Rock
The Liver Institute at Methodist Dallas Medical Center, Dallas
Liver Center of Texas, Dallas
Texas Digestive Disease Consultants, Dallas
UT Southwestern Medical Center, Dallas
Hôpital Pitié-Salpêtrierè, Paris
Texas Clinical Research Institute LLC, Arlington
CHU de Rouen-Centre Hospitalier Universitaire, Rouen
Baylor Scott and White All Saints Medical Center, Fort Worth
Texas Digestive Disease Consultants, Fort Worth
Baylor College of Medicine - Advanced Liver Therapies, Houston
The University of Texas Medical School at Houston, Houston
American Research Corporation, San Antonio
Clinical Trials of Texas, Inc., San Antonio
San Antonio Military Medical Center, Fort Sam Houston
Centex Studies, Inc., McAllen
Texas Digestive Disease Consultants, San Marcos
University of Colorado Denver and Hospital, Aurora
CHU Amiens Picardie, Amiens
South Denver Gastroenterology, PC, Englewood
Peak Gastroenterology Associates, Colorado Springs
Grand Teton Research Group, PLLC, Idaho Falls
Arizona Liver Health, Chandler
Arizona Liver Health, Glendale
The Institute for Liver Health, Tucson
Sierra Clinical Research, Las Vegas
Keck Hospital of USC, Los Angeles
Cedars-Sinani Medical Center, Los Angeles
California Liver Research Institute, Pasadena
Hope Clinical Research, Canoga Park
eStudySite, La Mesa
Scripps Whittier Diabetes Institute, La Jolla
Hôpital Beaujon- Service d'Hepatologie, Clichy
Palmtree Clinical Research, INC., Palm Springs
Inland Empire Liver Foundation, Rialto
University of California, San Francisco-Fresno, Fresno
University of California, San Francisco, San Francisco
Stanford University Medical Center, Palo Alto
Hôpital Paul Brousse, Villejuif
University of California, Davis Medical Center, Sacramento
Kaiser Permanente Sacramento Medical Center, Sacramento
Univeritätsklinkum Würzburg, Würzburg
Virginia Mason - Seattle Medical Center, Seattle
Harborview Medical Center, Seattle
University of Washington Medical Center, Seattle
Massachusetts General Hospital, Boston
Lahey Hospital & Medical Center, Burlington
UMass Memorial Health Care, Worcester
Amici GI-LLC, Martinsville
Rutgers New Jersey Medical School, Newark
University Gastroenterology, Providence
The University of Vermont Medical Center, Burlington
University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary
(G.I.R.I.) GI Research Institute, Vancouver
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax
Kent Place, Lindsay
London Health Sciences Centre-University Hospital, London
Office of Dr. Gauthier, North Bay
Toronto Liver Centre, Toronto
Clinique de medecine Urbaine du Quartier Latin, Montreal
Chronic Viral Illness/McGill University Health Centre (MUHC), Montreal
CHU de Nice, Hôpital de l'Archet 2, Nice
EUGASTRO GmbH, Leipzig
Universitätsklinikum Leipzig AöR, Leipzig
Synexus Polska Sp. z o.o., Oddział w Częstochowie, Częstochowa
Synexus Polska Sp. z.o.o., Oddział w Gdańsku, Gdansk
Synexus Polska Sp. Z.o.o., Oddział w Gdyni, Gdynia
Synexus Polska Sp. z o.o., Oddział w Katowicach, Katowice
Synexus Polska Sp. z o.o., Oddział w Łodzi, Lodz
Synexus Polska Sp. z o.o., Oddział w Poznaniu, Poznan
Synexus Polska Sp. z o.o., Oddział w Warszawie, Warsaw
Synexus Polska Sp. z o.o., Oddział w Wrocławiu, Wroclaw
Latin Clinical Trial Center, San Juan
Fundación de Investigación de Diego, San Juan
Hospital Clínic de Barcelona, Barcelona
Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department, Kyiv
"Kyiv Railway Clinical Hospital №2 of branch Health Center of the Joint-Stock Company Ukranian Railway, Day treatment department", Kyiv
Derby Teaching Hospitals NHS Foundation Trust, Derby
University Hospitals Birmingham NHS Foundation Trust, Birmingham
Royal Free Hospital NHS Foundation Trust, London
King's College Hospital NHS Foundation Trust, London
Imperial College Healthcare NHS Trust, St Mary's Hospital, London
Nottingham University Hospitals NHS Trust, Nottingham
Derriford Hospital, Plymouth
Oxford University Hospitals NHS Foundation Trust, Oxford
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY