334
Participants
Start Date
December 26, 2014
Primary Completion Date
December 23, 2021
Study Completion Date
December 23, 2021
Obeticholic Acid (OCA)
"Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants).~Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study."
Placebo
One tablet daily (or a lower frequency depending on CP score) for the remainder of the study
NZ Liver Transplant Unit, Auckland Hospital, Grafton
Cub Hôpital Erasme, Brussels
AKH, Medical University of Vienna, Vienna
CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A., Buenos Aires
Hospital De Clinicas University Of Buenos Aires, Buenos Aires
Hospital Italiano de Buenos Aires, Buenos Aires
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo, Buenos Aires
Centrol Integral de Gastroenterologia, Buenos Aires
St. Ivan Rilsky University Hospital, Sofia
Hospital Universitario Austral, Presidente Derqui
Dim Clínica Privada, Ramos Mejía
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Camperdown
Medicinsk klinik for mave, tarm-og leversygdomme, København Ø
University Hospital Antwerp, Edegem
Department of Gastroenterology & Hepatology, Nepean Hospital, Kingswood
Uz Leuven, Leuven
Inselspital, University Of Bern, UVCM, DMLL, Bern
St. Vincent's Hospital Melbourne, Fitzroy
Austin Hospital, Heidelberg
Box Hill Hospital, Box Hill
University Of Debrecen, Department Of Medicine, Division Of Gastroenterology, Debrecen
Gallipoli Medical Research Foundation, Brisbane
Gastroenterology, Christchurch Hospital, Christchurch
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide
Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S, Odense
Flinders Medical Centre, Adelaide
Ankara University School of Medicine Gastroenterology Dept., Ankara
Fiona Stanley Hospital, Gastroenterology Department, Murdoch
Consultorio Médico de la Dra Alma Laura Ladrón de Guevara Cetina, Mexico City
Aarhus University Hospital Department of Hepatology and Gastroenterology, Aarhus
USZ, Klinik für Gastroenterologie und Hepatologie, Zurich
University Hospital Ghent, Ghent
Kantonsspital St. Gallen, Clinic for Gastroeterologie and Hepatologie, Sankt Gallen
Mount Sinai Beth Israel, New York
Weill Cornell Medical College, New York
East Tallinn Central Hospital Gastroenterology Center, Tallinn
Clinic For Gastroenterology And Hepatology Clinical Center Of Serbia, Belgrade
Clinical Hospital Centre Zvezdara, Belgrade
Seoul National University Bundang Hospital, Seongnam-si
Departamento De Gastroenterologia. Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran, Mexico City
Medica Sur, S.A.B. de C.V., Mexico City
Karolinska University Hospital, Stockholm
University of Rochester Medical Center, Rochester
Hospital of the University of Pennsylvania, Philadelphia
Azienda Socio-Sanitarla Territoriale (ASST) Santi Paolo e Carlo, Milan
Univeritatsklinikum Hamburg Eppendorf, Medizinische Klinik und Poliklinik, Hamburg
Turku University Central Hospital, Gastroenterology Outpatient Clinic, Turku
Azienda Socio Sanitaria Territoriale (ASST) di Monza, Monza
Mercy Medical Center, Baltimore
McGuire DVAMC, Richmond
Hospital Universitario Puerta De Hierro Majadahonda, Majadahonda
Virgen De La Victoria University Hospital, Málaga
Gastrointestinal Specialists of Georgia, Marietta
Piedmont Atlanta Hospital, Atlanta
Emory University Hospital, Atlanta
Rambam Health Care Campus, Haifa
UF Hepatology Research at CTRB, Gainesville
Schiff Center for Liver Diseases/University of Miami, Miami
Chu De Bordeaux - Hôpital Haut Lévêque, Pessac
Ege University School of Medicine Gastroenterology Dept., Izmir
Azienda Ospedaliero - Universita di Padova, Padua
Quality Medical Research, PLLC, Nashville
Hospital Universitario Marqués De Valdecilla, Santander
Southern Therapy and Advanced Research (STAR), Jackson
AOU Policlinico Sant' Orsola Malpighi, Bologna
Azienda Ospedaliero Universitaria Sant´ Orsola Malpighi, Bologna
University of Louisville, Medical Dental Complex, Louisville
Hospital Universitario Virgen del Rocio, Seville
AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica, Modena
La Fe, Hospital ( Valence ), Valencia
Indiana University, Indianapolis
Indianapolis Gastroenterology Research Foundation, Indianapolis
Inje University Busan Paik Hospital, Busan
Henry Ford Health System, Novi
Rabin Medical Center, Petah Tikva
Pusan National University Hospital, Busan
Azienda Ospedaliero Universitaria Careggi Universita di Firenze, Florence
Tartu University Hospital, Tartu
Minnesota Gastroenterology, P.A., Saint Paul
CHRU Hôpital HURIEZ, Lille
Klinikum der Johann-Wolfgang Goethe, Universitaet Frankfurt am Main, Frankfurt am Main
Northwestern University Feinberg School of Medicine, Chicago
University of Chicago Medical Center, Chicago
Saint Louis University Gastroenterology & Hepatology, St Louis
Kansas City Research Institute, Kansas City
Sourasky Tel-Aviv Medical Center, Tel Aviv
Universitaetsklinikum Heidelberg Medizinische Universitaetsklinik, Heidelberg
Tulane University Medical Center, New Orleans
The Liver Institute at Methodist Dallas Medical Center, Dallas
Baylor University Medical Center, Dallas
Texas Digestive Disease Consultants, Dallas
UT Southwestern Medical Center, Dallas
Hospital Saint-Antoine, A.P.-H.P., Paris
Texas Digestive Disease Consultants, Southlake
Baylor Scott and White Research Institute, Fort Worth
Baylor College of Medicine - Advanced Liver Therapies, Houston
UT Health The University of Texas Health Science Center at Houston, Houston
American Research Corporation at Texas Liver Institute, San Antonio
Brooke Army Medical Center, Fort Sam Houston
University of Colorado Denver and Hospital, Aurora
University of Munich, LMU Klinikum Grosshadern, Munich
Soroka Medical Center, Beersheba
Clinical Research Centers of America, Murray
Mayo Clinic Arizona, Phoenix
Cedars-Sinai Medical Center, Los Angeles
AOU Policlinico Paolo Giaccone - Di.Bi.M.I.S, Palermo
Friedrich-Alexander-Uniersitat Erlangen, Erlangen
Inland Empire Liver Foundation, Rialto
Stanford University, Stanford
University of California Davis, Davis Medical Center, Sacramento
Swedish Organ Transplant & Liver Center, Seattle
Centro De Investigaciones Clínicas Viña Del Mar, Viña del Mar
UMass Medical School, Worcester
Saint Joseph's Regional Medical Center, Paterson
Centro De Hepatología, La Plata
Hospital Privado Universitario de Cordoba S.A., Córdoba
Hospital Provincial del Centenario, Rosario
Hospital Aleman, Buenos Aires
Hospital Britanico De Buenos Aires, Buenos Aires
Gastrocentro/ Universidade Estadual de Campinas (UNICAMP), São Paulo
Gastrocentro. Unidad Estadual de CAmpinas UNICAMP, Campinas
Instituto Hospital de Base do Distrito Federal-IHBDF, Brasília
Hospital Sao Rafael, São Salvador
Instituto Goiano de Gastroenterologia, Goiânia
Cepec Huufma, São Luís
Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG), Belo Horizonte
Hospital de Clinicas de Porto Alegre, Porto Alegre
Hospital Universitario Professor Edgard Santos, Bahia
Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO, Rio de Janeiro
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP, São Paulo
University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary
University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC), Edmonton
University Of Manitoba, Health Sciences Centre, Winnipeg
London Health Sciences Centre-University Hospital, London
University Health Network, Toronto General Hospital, Toronto
Chum, Montreal
Helsinki University Central Hospital, Helsinki
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Hanover
CHARITÉ, Campus Virchow Klinikum, Berlin
Universität Leipzig KöR, Medizinische Fakultät, Leipzig
Queen Mary Hospital, Hong Kong
Prince Of Wales Hospital, Hong Kong
Tuen Mun Hospital, Hong Kong
Alice Ho Miu Ling Nethersole Hospital, Hong Kong
Humanity & Health Research Centre, Hong Kong
Békés Megyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz, Békéscsaba
Szent János Hospital, Budapest
Hadassah Hebrew University Medical Center, Jerusalem
Shaare Zedek Medical Center, Jerusalem
Sheba Medical Center, Ramat Gan
Azienda Ospedaliero - Universitaria di Cagliari - Centro per lo Studio delle Malattie del Fegato, Monserrato
Università Politecnica delle Marche - Azienda Ospedaliero, Ancona
Policlinico Universitario Agostino Gemelli - Universita Cattolica del Sacro Cuore, Rome
Hospital of Lithuanian University of Health Sciences, Kauno klinikos, Kaunas
Vilnius University Hospital Santaros klinikos, Vilnius
Radboud UMC, Nijmegen
Vrije Universiteit Medisch Centrum (VUMC), Amsterdam
Erasmus Mc, Rotterdam
Amsterdam University Medical Centre (AMC), Amsterdam
University Medical Center Utrecht, Utrecht
Nzoz Vitamed, Bydgoszcz
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego, Pierwszy Oddzial Chorob Zakaznych, Wroclaw
Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii Onkologicznej, Warsaw
Medical University of Warsaw Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie (SPCSK in Warsaw, Warsaw
Oddział Gastr. I Hepat. Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibińskiego Sum, Katowice
Dep. Of Gastroenterology UM Lublin, Lublin
Centro Hospitalar Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon
Gangnam Severance Hospital, Seoul
Seoul National University Hospital, Seoul
Hospital Vall d'Hebron, Barcelona
Hospital Clinic de Barcelona, Barcelona
Sahlgrenska Universitetssjukhuset, Gothenburg
University Hospitals Bristol NHS Foundation Trust, Bristol
Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth
Gartnavel General Hospital, Glasgow
Forth Valley Royal Hospital, Larbert
Institute of Cellular Medicine, Newcastle upon Tyne
University Hospitals Birmingham NHS Foundation Trust, Birmingham
Cambrigde University Hospitals NHS Foundation Trust, Cambridge
The Royal Free Hospital, London
Nottingham University Hospital Nhs Trust, Nottingham
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY