Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

PHASE3CompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

December 17, 2018

Conditions
Primary Biliary Cirrhosis
Interventions
DRUG

Obeticholic Acid (OCA)

OCA was administered orally once daily and provided in tablet form in 2 strengths: 5 mg and 10 mg.

DRUG

Placebo

Matching placebo tablets were administered orally once daily.

Trial Locations (59)

1090

Medizinische Universität Wien, Vienna

2050

Royal Prince Alfred Hospital, Camperdown

3004

The Alfred Hospital, Melbourne

3084

Austin Hospital, Heidelberg

6020

Medizinische Universität Innsbruck, Innsbruck

6525

UMC St. Radboud, Nijmegen, Nijmegen

10003

Beth Israel Medical Center, New York

20089

Istituto Clinico Humanitas, Rozzano (MI)

20246

Universitätsklinikum Hamburg Eppendorf, Hamburg

23226

Liver Institute of Virginia, Richmond

23249

Virginia Commonwealth University/McGuire DVAMC, Richmond

23602

Liver Institute of Virginia, Newport News

27710

Duke University Medical Center, Durham

33604

Hopital Haut-Leveque, Pessac

35128

Azienda Ospedaliera di Padova - Gastroenterologia, Padua

40138

Dip. Medicina Clinica - Università di Bologna, Bologna

Dip. Medicina Clinica- Università di Bologna, Bologna

46202

Indiana University School of Medicine, Indianapolis

48377

Henry Ford Health System, Detroit

60590

Klinikum der Johann-Wolfgang Goethe Universität Frankfurt am Main, Frankfurt am Main

60637

University of Chicago, Chicago

63104

St. Louis University, St Louis

66421

Universitätsklinikum des Saarlandes, Homburg

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

80045

University of Colorado, Denver, Aurora

92037

Scripps Clinic, San Diego

95817

UC Davis Medical Center, Sacramento

98101

Swedish Medical Center, Seattle

B-3000

UZ Leuven, Leuven

M5T 2S8

Toronto Western Hospital Liver Centre, Toronto

H2X 3J4

CHUM Hôpital St-Luc, Montreal

D-52074

Universitätsklinikum Aachen, Aachen

D-91054

Friedrich-Alexander-Universität Erlangen, Erlangen

D-30625

Medizinische Hochschule Hannover, Hanover

D-69120

Medizinische Universitätsklinik, Heidelberg

D-44623

Gastroenterologische Gemeinschaftspraxis, Dres. Felten / Hartmann / Hüppe, Herne

04103

Universitätsklinikum Leipzig, Leipzig

D-81377

LMU Klinikum der Universität München, München

1081 HV

VUmc Amsterdam, Amsterdam

1105 AZ

AMC Amsterdam, Amsterdam

3508 GA

UMC Utrecht, Utrecht

40-660

All-Medicus, Katowice

40-752

Klinika Gastroenterologii i Hepatologii SP CSK im. prof. K. Gibinskiego SUM, Katowice

20-954

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin

70-361

"Niepubliczny Zakład Opieki Zdrowotnej SONOMED", Szczecin

02-781

Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii, Warsaw

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

SE-41345

Sahlgrenska University Hospital, Gothenburg

B15 2TH

Queen Elizabeth Hospital, Birmingham

BS2 8HW

Bristol Royal Infirmary, Bristol

DD1 9SY

Ninewells Hospital Dundee, Dundee

FK5 4WR

Forth Valley Royal Hospital, Larbert

NW3 2QG

The Royal Free Hospital, London

M13 9WL

Manchester Royal Infirmary, Manchester

NE2 4 HH

Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

OX3 9DU

Oxford University Hospitals Trust, Oxford

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY

NCT01473524 - Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis | Biotech Hunter | Biotech Hunter