217
Participants
Start Date
January 31, 2012
Primary Completion Date
December 31, 2013
Study Completion Date
December 17, 2018
Obeticholic Acid (OCA)
OCA was administered orally once daily and provided in tablet form in 2 strengths: 5 mg and 10 mg.
Placebo
Matching placebo tablets were administered orally once daily.
Medizinische Universität Wien, Vienna
Royal Prince Alfred Hospital, Camperdown
The Alfred Hospital, Melbourne
Austin Hospital, Heidelberg
Medizinische Universität Innsbruck, Innsbruck
UMC St. Radboud, Nijmegen, Nijmegen
Beth Israel Medical Center, New York
Istituto Clinico Humanitas, Rozzano (MI)
Universitätsklinikum Hamburg Eppendorf, Hamburg
Liver Institute of Virginia, Richmond
Virginia Commonwealth University/McGuire DVAMC, Richmond
Liver Institute of Virginia, Newport News
Duke University Medical Center, Durham
Hopital Haut-Leveque, Pessac
Azienda Ospedaliera di Padova - Gastroenterologia, Padua
Dip. Medicina Clinica - Università di Bologna, Bologna
Dip. Medicina Clinica- Università di Bologna, Bologna
Indiana University School of Medicine, Indianapolis
Henry Ford Health System, Detroit
Klinikum der Johann-Wolfgang Goethe Universität Frankfurt am Main, Frankfurt am Main
University of Chicago, Chicago
St. Louis University, St Louis
Universitätsklinikum des Saarlandes, Homburg
University of Texas Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
University of Colorado, Denver, Aurora
Scripps Clinic, San Diego
UC Davis Medical Center, Sacramento
Swedish Medical Center, Seattle
UZ Leuven, Leuven
Toronto Western Hospital Liver Centre, Toronto
CHUM Hôpital St-Luc, Montreal
Universitätsklinikum Aachen, Aachen
Friedrich-Alexander-Universität Erlangen, Erlangen
Medizinische Hochschule Hannover, Hanover
Medizinische Universitätsklinik, Heidelberg
Gastroenterologische Gemeinschaftspraxis, Dres. Felten / Hartmann / Hüppe, Herne
Universitätsklinikum Leipzig, Leipzig
LMU Klinikum der Universität München, München
VUmc Amsterdam, Amsterdam
AMC Amsterdam, Amsterdam
UMC Utrecht, Utrecht
All-Medicus, Katowice
Klinika Gastroenterologii i Hepatologii SP CSK im. prof. K. Gibinskiego SUM, Katowice
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin
"Niepubliczny Zakład Opieki Zdrowotnej SONOMED", Szczecin
Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii, Warsaw
Hospital Vall d'Hebron, Barcelona
Hospital Clinic de Barcelona, Barcelona
Sahlgrenska University Hospital, Gothenburg
Queen Elizabeth Hospital, Birmingham
Bristol Royal Infirmary, Bristol
Ninewells Hospital Dundee, Dundee
Forth Valley Royal Hospital, Larbert
The Royal Free Hospital, London
Manchester Royal Infirmary, Manchester
Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne
Nottingham University Hospitals NHS Trust, Nottingham
Oxford University Hospitals Trust, Oxford
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY