Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

PHASE4TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

June 22, 2018

Primary Completion Date

July 9, 2021

Study Completion Date

July 9, 2021

Conditions
Liver Cirrhosis, Biliary
Interventions
DRUG

Obeticholic Acid (OCA)

OCA will be administered per dose and schedule specified in the arm description.

DRUG

Placebo

OCA matching placebo will be administered per the schedule specified in the arm description.

Trial Locations (40)

1070

CUB Hospital Erasme, Brussels

2050

Royal Prince Alfred Hospital, Camperdown

2747

Nepean Hospital, Kingswood

3000

University Hospital Leuven, Leuven

8035

Paseo Vall d'Hebron, Barcelona

10617

West Tallinn Central Hospital, Tallinn

15213

UPMC Center for Liver Diseases, Pittsburgh

20900

Azienda Socio Sanitaria Territoriale (ASST) di Monza, Monza

21202

Mercy Medical Center, Baltimore

33136

Schiff Center for Liver Diseases/ University of Miami, Miami

41013

Hospital Universitario Virgen del Rocio, Seville

41126

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

43210

The Ohio State University Wexner Medical Center, Columbus

46026

Hospital Universitari I Politecnic La Fe de Valencia, Valencia

48109

University Of Michigan, Ann Arbor

64131

Kansas City Research Institute, Kansas City

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

77030

Baylor College of Medicine- Advanced Liver Therapies, Houston

78215

American Research Corporation at theTexas Liver Institute, San Antonio

92377

Inland Empire Liver Foundation, Rialto

95817

University of California, Ddavis Medical Center, Sacramento

Unknown

Hospital Italiano de Buenos Aires, Buenos Aires

Hospital Universitario Austral, Buenos Aires

Hospital Aleman, Caba

Hospital Britanico de Buenos Aires, Caba

"Hospital de Gastroenterologia Dr Carlos Bonorino Udaondo", Ciudad Autonoma de Buenos Aire

Hospital Universitario Austral, Pilar

Hospital Provincial del Centenario, Rosario

Universitair Ziekenhuis Antwerpen UZA, Edegem

Hospital das Clínicas da Universidade Federal de Minas Gerais - UFMG, Belo Horizonte

Hospital de Clinicas de Porto Alegre, Rio Grande

Toronto General Hospital, Toronto

Tartu University Hospital, Tartu

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat-Gasztroenterologia-Hepatologia, Békéscsaba

Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas

Vilnius University Hospital Santaros Klinikos, Vilnius

M5500DPS

Higea S.A., Mendoza

054003-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

04103

Universitatsklinikum Leipzig AoR, Leipzig

LT-92288

Klaipeda Seamen's Hospital, Klaipėda

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY