Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

PHASE4TerminatedINTERVENTIONAL
Enrollment

334

Participants

Timeline

Start Date

December 26, 2014

Primary Completion Date

December 23, 2021

Study Completion Date

December 23, 2021

Conditions
Liver Cirrhosis, Biliary
Interventions
DRUG

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."

DRUG

Placebo

One tablet daily (or a lower frequency depending on CP score) for the remainder of the study

Trial Locations (181)

1023

NZ Liver Transplant Unit, Auckland Hospital, Grafton

1070

Cub Hôpital Erasme, Brussels

1090

AKH, Medical University of Vienna, Vienna

1119

CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A., Buenos Aires

1120

Hospital De Clinicas University Of Buenos Aires, Buenos Aires

1181

Hospital Italiano de Buenos Aires, Buenos Aires

1264

Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo, Buenos Aires

1425

Centrol Integral de Gastroenterologia, Buenos Aires

1431

St. Ivan Rilsky University Hospital, Sofia

1629

Hospital Universitario Austral, Presidente Derqui

1704

Dim Clínica Privada, Ramos Mejía

2050

AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Camperdown

2100

Medicinsk klinik for mave, tarm-og leversygdomme, København Ø

2650

University Hospital Antwerp, Edegem

2747

Department of Gastroenterology & Hepatology, Nepean Hospital, Kingswood

3000

Uz Leuven, Leuven

3010

Inselspital, University Of Bern, UVCM, DMLL, Bern

3065

St. Vincent's Hospital Melbourne, Fitzroy

3084

Austin Hospital, Heidelberg

3128

Box Hill Hospital, Box Hill

4032

University Of Debrecen, Department Of Medicine, Division Of Gastroenterology, Debrecen

4120

Gallipoli Medical Research Foundation, Brisbane

4710

Gastroenterology, Christchurch Hospital, Christchurch

5000

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide

Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S, Odense

5042

Flinders Medical Centre, Adelaide

6100

Ankara University School of Medicine Gastroenterology Dept., Ankara

6150

Fiona Stanley Hospital, Gastroenterology Department, Murdoch

6700

Consultorio Médico de la Dra Alma Laura Ladrón de Guevara Cetina, Mexico City

8000

Aarhus University Hospital Department of Hepatology and Gastroenterology, Aarhus

8091

USZ, Klinik für Gastroenterologie und Hepatologie, Zurich

9000

University Hospital Ghent, Ghent

9007

Kantonsspital St. Gallen, Clinic for Gastroeterologie and Hepatologie, Sankt Gallen

10003

Mount Sinai Beth Israel, New York

10021

Weill Cornell Medical College, New York

10138

East Tallinn Central Hospital Gastroenterology Center, Tallinn

11000

Clinic For Gastroenterology And Hepatology Clinical Center Of Serbia, Belgrade

Clinical Hospital Centre Zvezdara, Belgrade

13620

Seoul National University Bundang Hospital, Seongnam-si

14000

Departamento De Gastroenterologia. Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran, Mexico City

14050

Medica Sur, S.A.B. de C.V., Mexico City

14186

Karolinska University Hospital, Stockholm

14642

University of Rochester Medical Center, Rochester

19104

Hospital of the University of Pennsylvania, Philadelphia

20142

Azienda Socio-Sanitarla Territoriale (ASST) Santi Paolo e Carlo, Milan

20246

Univeritatsklinikum Hamburg Eppendorf, Medizinische Klinik und Poliklinik, Hamburg

20521

Turku University Central Hospital, Gastroenterology Outpatient Clinic, Turku

20900

Azienda Socio Sanitaria Territoriale (ASST) di Monza, Monza

21202

Mercy Medical Center, Baltimore

23249

McGuire DVAMC, Richmond

28222

Hospital Universitario Puerta De Hierro Majadahonda, Majadahonda

29010

Virgen De La Victoria University Hospital, Málaga

30060

Gastrointestinal Specialists of Georgia, Marietta

30309

Piedmont Atlanta Hospital, Atlanta

30322

Emory University Hospital, Atlanta

31096

Rambam Health Care Campus, Haifa

32610

UF Hepatology Research at CTRB, Gainesville

33163

Schiff Center for Liver Diseases/University of Miami, Miami

33604

Chu De Bordeaux - Hôpital Haut Lévêque, Pessac

35100

Ege University School of Medicine Gastroenterology Dept., Izmir

35128

Azienda Ospedaliero - Universita di Padova, Padua

37211

Quality Medical Research, PLLC, Nashville

39008

Hospital Universitario Marqués De Valdecilla, Santander

39216

Southern Therapy and Advanced Research (STAR), Jackson

40138

AOU Policlinico Sant' Orsola Malpighi, Bologna

Azienda Ospedaliero Universitaria Sant´ Orsola Malpighi, Bologna

40202

University of Louisville, Medical Dental Complex, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

41126

AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica, Modena

46026

La Fe, Hospital ( Valence ), Valencia

46202

Indiana University, Indianapolis

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

47392

Inje University Busan Paik Hospital, Busan

48377

Henry Ford Health System, Novi

49100

Rabin Medical Center, Petah Tikva

49241

Pusan National University Hospital, Busan

50139

Azienda Ospedaliero Universitaria Careggi Universita di Firenze, Florence

51014

Tartu University Hospital, Tartu

55114

Minnesota Gastroenterology, P.A., Saint Paul

59037

CHRU Hôpital HURIEZ, Lille

60590

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

60637

Northwestern University Feinberg School of Medicine, Chicago

University of Chicago Medical Center, Chicago

63104

Saint Louis University Gastroenterology & Hepatology, St Louis

64131

Kansas City Research Institute, Kansas City

64239

Sourasky Tel-Aviv Medical Center, Tel Aviv

69120

Universitaetsklinikum Heidelberg Medizinische Universitaetsklinik, Heidelberg

70112

Tulane University Medical Center, New Orleans

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75246

Baylor University Medical Center, Dallas

Texas Digestive Disease Consultants, Dallas

75390

UT Southwestern Medical Center, Dallas

75571

Hospital Saint-Antoine, A.P.-H.P., Paris

76092

Texas Digestive Disease Consultants, Southlake

76104

Baylor Scott and White Research Institute, Fort Worth

77030

Baylor College of Medicine - Advanced Liver Therapies, Houston

UT Health The University of Texas Health Science Center at Houston, Houston

78215

American Research Corporation at Texas Liver Institute, San Antonio

78234

Brooke Army Medical Center, Fort Sam Houston

80045

University of Colorado Denver and Hospital, Aurora

81377

University of Munich, LMU Klinikum Grosshadern, Munich

84104

Soroka Medical Center, Beersheba

84123

Clinical Research Centers of America, Murray

85054

Mayo Clinic Arizona, Phoenix

90048

Cedars-Sinai Medical Center, Los Angeles

90127

AOU Policlinico Paolo Giaccone - Di.Bi.M.I.S, Palermo

91054

Friedrich-Alexander-Uniersitat Erlangen, Erlangen

92377

Inland Empire Liver Foundation, Rialto

94304

Stanford University, Stanford

95817

University of California Davis, Davis Medical Center, Sacramento

98104

Swedish Organ Transplant & Liver Center, Seattle

2540488

Centro De Investigaciones Clínicas Viña Del Mar, Viña del Mar

01655

UMass Medical School, Worcester

07503

Saint Joseph's Regional Medical Center, Paterson

B1902AWL

Centro De Hepatología, La Plata

X5016KEH

Hospital Privado Universitario de Cordoba S.A., Córdoba

S2002KDS

Hospital Provincial del Centenario, Rosario

C1118AAT

Hospital Aleman, Buenos Aires

C1280AEB

Hospital Britanico De Buenos Aires, Buenos Aires

13083-878

Gastrocentro/ Universidade Estadual de Campinas (UNICAMP), São Paulo

Gastrocentro. Unidad Estadual de CAmpinas UNICAMP, Campinas

70335-900

Instituto Hospital de Base do Distrito Federal-IHBDF, Brasília

41253-190

Hospital Sao Rafael, São Salvador

74535-170

Instituto Goiano de Gastroenterologia, Goiânia

65020-600

Cepec Huufma, São Luís

30130-100

Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG), Belo Horizonte

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

40110-060

Hospital Universitario Professor Edgard Santos, Bahia

20270-004

Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO, Rio de Janeiro

05403-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP, São Paulo

T2N-4Z6

University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary

T6G 2X8

University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC), Edmonton

R3E 3P6

University Of Manitoba, Health Sciences Centre, Winnipeg

N6A 5A5

London Health Sciences Centre-University Hospital, London

M5G 2C4

University Health Network, Toronto General Hospital, Toronto

H2X 3J4

Chum, Montreal

00290

Helsinki University Central Hospital, Helsinki

D-30625

Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Hanover

D-13353

CHARITÉ, Campus Virchow Klinikum, Berlin

04103

Universität Leipzig KöR, Medizinische Fakultät, Leipzig

Unknown

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

H-5600

Békés Megyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz, Békéscsaba

H-1125

Szent János Hospital, Budapest

POB 12000, 91120

Hadassah Hebrew University Medical Center, Jerusalem

91031 02

Shaare Zedek Medical Center, Jerusalem

52656 01

Sheba Medical Center, Ramat Gan

09042

Azienda Ospedaliero - Universitaria di Cagliari - Centro per lo Studio delle Malattie del Fegato, Monserrato

71-60126

Università Politecnica delle Marche - Azienda Ospedaliero, Ancona

00168

Policlinico Universitario Agostino Gemelli - Universita Cattolica del Sacro Cuore, Rome

LT 50009

Hospital of Lithuanian University of Health Sciences, Kauno klinikos, Kaunas

LT-08661

Vilnius University Hospital Santaros klinikos, Vilnius

6525 GA

Radboud UMC, Nijmegen

1081HV

Vrije Universiteit Medisch Centrum (VUMC), Amsterdam

3015 CE

Erasmus Mc, Rotterdam

1105 AZ

Amsterdam University Medical Centre (AMC), Amsterdam

3584CX

University Medical Center Utrecht, Utrecht

85-078

Nzoz Vitamed, Bydgoszcz

51-149

Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego, Pierwszy Oddzial Chorob Zakaznych, Wroclaw

02-781

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

02-097

Medical University of Warsaw Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie (SPCSK in Warsaw, Warsaw

40-752

Oddział Gastr. I Hepat. Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibińskiego Sum, Katowice

20-094

Dep. Of Gastroenterology UM Lublin, Lublin

1649-035

Centro Hospitalar Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon

06273

Gangnam Severance Hospital, Seoul

03080

Seoul National University Hospital, Seoul

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

413 45

Sahlgrenska Universitetssjukhuset, Gothenburg

BS2 8HW

University Hospitals Bristol NHS Foundation Trust, Bristol

PL6 8DH

Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth

G12 0YN

Gartnavel General Hospital, Glasgow

FK5 4WR

Forth Valley Royal Hospital, Larbert

NE2 4HH

Institute of Cellular Medicine, Newcastle upon Tyne

B15 2GW

University Hospitals Birmingham NHS Foundation Trust, Birmingham

CB2 0QQ

Cambrigde University Hospitals NHS Foundation Trust, Cambridge

NW3 2QG

The Royal Free Hospital, London

NG7 2UH

Nottingham University Hospital Nhs Trust, Nottingham

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY