2,477
Participants
Start Date
September 22, 2015
Primary Completion Date
September 15, 2023
Study Completion Date
September 15, 2023
Obeticholic Acid
Placebo
NZ Liver Transplant Unit, Grafton
ULB Hȏpital Erasme - Gastroenterology, Brussels
Medizinische Universität Wien, Vienna
Egyesitett Szent Istvan és Szent Laszlo, Budapest
UCL Saint-Luc - Hepatology Department, Brussels
Middlemore Hospital, Auckland
AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital, Camperdown
Westmead Hospital, Westmead
UZ Antwerpen, Edegem
Copenhagen University Hospital Hvidovre, Hvidovre
Nepean Hospital, Kingswood
UZ Leuven Campus Gathuisberg Hepatology Department, Leuven
The Alfred Hospital, Department of Gastroenterology, Melbourne
UVCM Hepatologie, Bern
The Royal Melbourne Hospital, Parkville
Austin Hospital, Heidelberg
Monash Health - Monash Medical Centre, Clayton
Ziekenhuis Oost-Limburg (ZOL), Genk
Ordensklinikum Linz GmbH, Linz
Royal Brisbane and Women's Hospital, Herston
Kenezy Gyula Korhaz es Rendelointezet, Debrecen
Gallipoli Medical Research Foundation, Greenslopes
Royal Adelaide Hospital Gastroenterology and Hepatology Dept., Adelaide
Odense University Hospital, Odense
Uniklinikum Salzburg, Salzburg
Flinders Medical Centre, Bedford Park
Universitätsklinik für Innere Medizin I Innsbruck, Innsbruck
Fiona Stanley Hospital, Murdoch
Hôpital de l'Archet II-CHU Nice, Nice
Epatocentro Ticino, Lugano
Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz, Budapest
University Clinic of Gastroenterology & Hepatology, Zurich
Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling, Aarhus
UZ Gent Gastroenterology Department, Ghent
Aalborg University Hospital, Aalborg
Hospital of St. Gallen, Sankt Gallen
Klinikum Klagenfurt am Wörthersee, Klagenfurt
AZ Nikolaas, Sint-Niklaas
Mount Sinai Beth Israel, New York
Concorde Medical Group PLLC, New York
New York University (NYU) Langone Medical Center, New York
Weill Cornell Medical College, New York
Icahn School of Medicine at Mt. Sinai, New York
Columbia University Medical Center, New York
A.O.U. Città della Salute e della Scienza di Torino, Torino
Montefiore Medical Center, The Bronx
University Medical Centar Zvezdara, Belgrade
Clinical Hospital Center Bezanijska Kosa, Belgrade
Hôpital Saint Joseph, Marseille
Charite Universitätsmedizin Campus Virchow, Berlin
University at Buffalo, Clinical and Translational Research Center, Buffalo
University of Rochester Medical Center, Rochester
UPMC, Pittsburgh
Hospital Clinico Universitario de Santiago, Santiago de Compostela
Holy Family Medical Center, Nazareth
The Pennsylvania State University and The Milton S. Hershey Medical Center, Hershey
Clinical Center Nis, Niš
Doylestown Health Gastroenterology, Doylestown
Hillmont GI, pc, Flourtown
Drexel University, Philadelphia
Hospital of the University of Pennsylvania, Philadelphia
Thomas Jefferson University, Philadelphia
Einstein Healthcare Network, Philadelphia
Hillmont G.I. - Lansdale Office, Lansdale
Hospital Universitario Donostia, Donostia / San Sebastian
Istituto Clinico Humanitas, Rozzano
Fondazione IRCCS Ca Granda Ospedale, Milan
Ospedale san Giuseppe - Multimedica, Milan
Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo, Milan
Universitätsklinikum Hamburg- Eppendorf, Hamburg
Turku University Hospital, Turku
Walter Reed National Military Medical Center, Bethesda
Mercy Medical Center, Baltimore
Johns Hopkins Hospital, Baltimore
Investigative Clinical Research, Annapolis
Inova Fairfax Medical Campus, Falls Church
West Galilee Hospital, Nahariya
University of Virginia Health System, Charlottesville
Bon Secours St. Mary's Hospital, Richmond
McGuire DVAMC GI, Richmond
Virginia Commonwealth University Clinical Research Services Unit (CRSU), Richmond
Digestive and Liver Disease Specialists, Norfolk
Complejo Asistencial Universitario de Leon, León
Hepato-Gastroenterology Center Kiel, Kiel
Digestive Health Specialists, PA, Winston-Salem
Duke University Medical Center, Durham
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario La Paz, Madrid
Carolinas Center for Liver Disease/Carolinas HeatlhCare System, Huntersville
Center for Liver Disease, Charlotte
Charlotte Gastroenterology & Hepatology, Charlotte
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda
Cumberland Research Associates, LLC, Fayetteville
Asheville Gastroenterology Associates, PA, Asheville
Hospital Universitario Fundación Alcorcon, Alcorcón
Hospital (Universitario) Virgen de la Victoria, Málaga
Prisma Health- Upstate Gastroenterology and Liver Center, Greenville
Gastrointestinal Specialists of Georgia, Marietta
Digestive Healthcare of Georgia, Atlanta
Piedmont Atlanta Hospital, Atlanta
The Emory Clinic (TEC), Atlanta
Summit Clinical Research, LLC, Athens
Medizinische Hochschule Hannover, Hanover
CHU Toulouse - Hopital de Purpan, Toulouse
UF Health Jacksonville-Gastroenterology Emerson, Jacksonville
Mayo Clinic, Jacksonville
UF Hepatology Research at CTRB, Gainesville
Meridien Research, Maitland
Florida Hospital Transplant Institute, Orlando
Bruce W. Carter Miami VA Medical Center, Miami
Schiff Center for Liver Diseases, Miami
Integrity Clinical Research, LLC, Doral
ProLive Medical Research, Miami
Janus Clinical Research, Inc., Miami
Sunrise Medical Research, Inc., Lauderdale Lakes
South Florida Center of Gastroenterology, P.A., Wellington
Florida Medical Clinic, P.A., Zephyrhills
Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN, Pessac
Florida Digestive Health Specialist Research Institute, Lakewood Rch
Carmel Medical Center, Haifa
Nature Coast Clinical Research, Inverness
Sensible Healthcare, LLC, Ocoee
The University of Alabama at Birmingham, Birmingham
Digestive Health Specialists of the Southeast, Dothan
Associates in Gastroenterology, PLC, Hermitage
Nashville Gastrointestinal Specialists, Nashville
Quality Medical Research, PLLC, Nashville
Vanderbilt University Medical Center, Nashville
WR-Clinsearch, LLC, Chattanooga
East Tennesse Research Institute, Johnson City
Methodist Healthcare, University Hospital, Memphis
Gastro One, Germantown
Centre hospitalier Pierre Oudot, Bourgoin
Clinical Research Solutions, Jackson
CHU Grenoble, Grenoble
Hospital (Universitario) Marqués de Valdecilla, Santander
Southern Therapy and Advanced Research, LLC, Jackson
Universita di Bologna - DIMEC, Bologna
University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC, Bologna
University of Louisville Medical, Clinical Trials Unit, Louisville
University of Kentucky Chandler Medical Center, Lexington
Hospital Universitario Virgen del Rocio, Seville
AOU di Modena Ospedale Civile, Modena
The Medical Center of Bowling Green, Bowling Green
The Ohio State University Wexner Medical Center, Columbus
University Hospitals Case Medical Center, Cleveland
MetroHealth Medical Center, Cleveland
Gastroenterologische Gemeinschaftspraxis, Herne
St. Josef-Hospital, Ruhr University Bochum, Bochum
Service d'Hepato-Gastroenterologie CHR Orleans - La Source, Orléans
University Hospital Essen, Essen
Consultants for Clinical Research, Cincinnati
Katholische Kliniken Ruhrhalbinsel GmbH, Essen
Hospital Clinico Universitario de Valencia, Valencia
Consorcio Hospital General Universitario, Valencia
Hospital Universitario La Fe., Valencia
Indiana University Health University Hospital, Indianapolis
Indianapolis Gastroenterology & Hepatology, Indianapolis
Huron Gastroenterology Associates/Center for Digestive Care, Ypsilanti
Henry Ford Health System, Detroit
Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research, Wyoming
CHU Angers-Service d'Hepato-Gastroenterologie, Angers
Hospital Universitario Miguel Servet, Zaragoza
University Hosptial Cologne Clinics for Gastroenterology and Hepatology, Cologne
Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III, Aachen
Sheba Medical Center, Ramat Gan
University of Wisconsin Hospital & Clinics, Madison
CHU de Nancy - Hôpital de Brabois adultes, Vandœuvre-lès-Nancy
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik, Mainz
Minnesota Gastroenterology, Minneapolis
Mayo Clinic, Rochester
Rapid City Medical Center, Rapid City
CHRU Hôpital Claude Huriez, Lille
Loyola University Medical Center, Maywood
Northwestern University, Feinberg School of Medicine, Chicago
The University of Chicago Medical Center, Chicago
Saint Louis University Gastroenterology & Hepatology, St Louis
Washington University School of Medicine - Gastroenterology, St Louis
Kansas City VA Medical Center, Kansas City
Kansas City Research Institute, Kansas City
Sourasky Tel-Aviv Medical Center, Tel Aviv
The University of Kansas Medical Center, Kansas City
CHI Health Alegent Creighton Clinic Gastroenterology, Omaha
Hôpital de la Croix Rousse, Lyon
Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie, Heidelberg
Tulane Medical Center, New Orleans
Ochsner Clinic Foundation, New Orleans
Louisiana Research Center, LLC, Shreveport
Arkansas Gastroenterology, North Little Rock
Liver Wellness Center, Little Rock
INTEGRIS Baptist Medical Center, Oklahoma City
Hospital Saint Antoine Department of Hepatology, Paris
Hôpital de la Pitié Salpétrère, Paris
Hôpital Cochin, Paris
The Liver Institute at Methodist Dallas Medical Center, Dallas
Liver Center of Texas, Dallas
Texas Digestive Disease Consultants, Dallas
UT Southwestern Medical Center, Dallas
Texas Clinical Research Institute, Arlington
CHU de Rouen, Rouen
Baylor Scott & White All Saints Medical Center, Fort Worth
Texas Digestive Disease Consultants, Fort Worth
Baylor College of Medicine Ben Taub General Hospital, Houston
Baylor College of Medicine, Houston
Houston Methodist Hospital, Houston
Liver Associates of Texas, P.A., Houston
The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition, Houston
Centex Studies, Inc., Houston
American Research Corporation at the Texas Liver Institute, San Antonio
Gastroenterology Consultants of San Antonio, San Antonio
Brooke Army Medical Center, Fort Sam Houston
Centex Studies, Inc., McAllen
Texas Digestive Disease Consultants - San Marcos, San Marcos
MedResearch, Inc., El Paso
Western States Clinical Research, Inc., Wheat Ridge
University of Colorado Denver and Hospital, Aurora
CHU Amiens Picardie, Amiens
South Denver Gastroenterology, PC, Englewood
Azienda Ospedaliera Universitaria Policlinico, Napoli
Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie, Munich
Grand Teton Research Group, Idaho Falls
Soroka Medical Center Division of Internal Medicine, Beersheba
University of Utah Hospital, Salt Lake City
St. Joseph's Hospital and Medical Center, Phoenix
Mayo Clinic Arizona, Phoenix
Institute for Liver Health DBA Arizona Liver Health, Chandler
Arizona Liver Health - Glendale, Glendale
Arizona Liver Clinic - Tucson, Tucson
AccumetRx Clinical research / UGNM, Albuquerque
Keck Medical Center of USC, Los Angeles
Cedars-Sinai Medical Center, Los Angeles
National Research Institute, Wilshire, Los Angeles
Gastrointestinal Biosciences, Los Angeles
Veteran Affairs Great Los Angeles Healthcare System, Los Angeles
Policlinico Paolo Giaccone di Palermo, Palermo
Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1, Erlangen
Hadassah Ein Kerem MC, Jerusalem
Citrus Valley Gastroenterology, Covina
GW Research Inc., Chula Vista
Precision Research Institute, Chula Vista
TriWest Research Associates, LLC, El Cajon
Scripps Clinic, La Jolla
University of California, San Diego, La Jolla
CHU Beaujon-Service d'Hépatologie, Clichy
Southern California Research Center, Coronado
eStudy Site, San Diego
Medical Associates Research Group, San Diego
Kaiser Permanente, San Diego
Inland Empire Liver Foundation, Rialto
UCSF Fresno, Clinical Research Center, Fresno
Fresno Clinical Research Center, Fresno
Hôpital Henri Mondor - Service d'hépatologie, Créteil
California Pacific Medical Center (CPMC), San Francisco
UCSF/ San Francisco General Hospital, San Francisco
Quest Clinical Research, San Francisco
University of California, San Francisco, San Francisco
Stanford University, Palo Alto
Hopital Paul Brousse, Villejuif
Silicon Valley Research Institute, San Jose
University of California Davis Medical Center, Sacramento
The Queen's Medical Center - Liver Center, Honolulu
Universitätsklinikum Würzburg, Würzburg
Virginia Mason - Seattle Medical Center, Seattle
Swedish Organ Transplant and Liver Center, Seattle
Liver Institute Northwest, Seattle
University of Washington Medical Center, Seattle
Rambam Medical Center Center for Liver diseases, Haifa
Rabin Medical Center, Liver Institute, Petah Tikva
Yale University School of Medicine, New Haven
Massachusetts General Hospital, Boston
Boston Medical Center, Boston
Beth Israel Deaconess Medical Center, Boston
Lahey Hospital & Medical Center, Burlington
University of Massachusetts Medical School, Worcester
AGA Clinical Research Associates, LLC, Egg Harbor
Amici Clinical Research, Martinsville
Amici GI - LLC, Martinsville
Rutgers University New Jersey Medical School, Newark
Saint Joseph's Regional Medical Center, Paterson
University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill
University of Cincinnati, Cincinnati
University Gastroenterology, Providence
The University of Vermont Medical Center - Smith 2, Burlington
AZ Sint-Jan Brugge Oostende, Bruges
London Health Sciences Centre University Hospital, London
University of Calgary Liver Unit, Calgary
GI Research, Edmonton
University of Alberta, Edmonton
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal, Montreal
The Research Institute of the McGill University Health Centre, Montreal
Toronto Center for Liver Disease, Toronto
Toronto Liver Centre, Toronto
LAIR Centre, Vancouver
Gordon and Leslie Diamond Health Care Centre, Vancouver
GIRI - GI Research Institute, Vancouver
PerCuro Clinical Research Ltd., Victoria
John Buhler Research Centre, Winnipeg
Helsinki University Hospital, Helsinki
Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie, Leipzig
EUGASTRO GmbH, Leipzig
Shaarei Zedek Medical Center, Jerusalem
Fondazione IRCCS Ca Grande Ospedale, Milan
Policlinico University Campus Biomedico, Rome
Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice
Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego, Lodz
Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin
Centrum Badan Klinicznych Piotr Napora, Wroclaw
Centro Hospitalar do Baixo Vouga, E.P.E., Aveiro
Ulsba, Epe, Beja
Hospital da Senhora da Oliveira - Guimarães, Guimarães
Centro Hospitalar Lisboa Ocidental, Lisbon
Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria, Lisbon
Klinical Investigations Group, LLC, San Juan
Ave Ponce De Leon #715, San Juan
Fundacion de Investigacion, San Juan
Hospital Universitari Son Espases, Palma de Mallorca
Hospital General y Universitario de Alicante, Alicante
Hospital del Mar Gastroenterology Department, Barcelona
Hospital Universitario Vall d'Hebron, Barcelona
Hospital Clinic(o) de Barcelona, Barcelona
Sahlgrenska University Hospital, Gothenburg
Universitetsjukhuset Linkoping, Linköping
Karolinska University Hospital, Stockholm
Royal Cornwall Hospital, Truro
Royal Bournemouth Hospital, Bournemouth
Queen Alexandra Hospital, Portsmouth
Norfolk and Norwich University Hospitals, Norwich
John Radcliffe Hospital, Headington
Royal Surrey NHS Foundation Trust, Guildford
Institute of Biomedical Research, Birmingham
Bradford Royal Infirmary, Bradford
University Hospital Bristol NHS Foundation Trust, Bristol
Cambridge University Hospital, Cambridge
University Hospitals Coventry & Warwickshire, Coventry
Glasgow Royal Infirmary, NHS Greater, Glasgow
Gastroenterology Department Hull Royal Infirmary, Hull
University Hospital Aintree, Liverpool
Royal London Hospital, London
Institute for Liver and Digestive Health, London
Guy's and St. Thomas NHS Foundation Trust, London
St. Mary's Hospital, London
Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary, Manchester
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne
Nottingham Digestive Diseases and Biomedical Research Unit, Nottingham
Derriford Hospital, Plymouth
Lead Sponsor
Intercept Pharmaceuticals
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