Obeticholic Acid (OCA)

DRUG5 trials

Sponsors

Intercept Pharmaceuticals

Conditions

Liver Cirrhosis, BiliaryPrimary Biliary CirrhosisPrimary Sclerosing Cholangitis (PSC)

Phase 2

Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

CompletedNCT00570765

Intercept PharmaceuticalsLiver Cirrhosis, Biliary

Start: 2008-01-17End: 2017-09-25Updated: 2021-06-22

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

CompletedNCT02177136

Intercept PharmaceuticalsPrimary Sclerosing Cholangitis (PSC)

Start: 2015-02-09End: 2018-03-22Updated: 2021-07-08

Phase 3

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

CompletedNCT01473524

Intercept PharmaceuticalsPrimary Biliary Cirrhosis

Start: 2012-01-31End: 2018-12-17Updated: 2021-05-06

Phase 4

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

TerminatedNCT02308111

Intercept PharmaceuticalsLiver Cirrhosis, Biliary

Start: 2014-12-26End: 2021-12-23Updated: 2023-03-09

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

TerminatedNCT03633227

Intercept PharmaceuticalsLiver Cirrhosis, Biliary

Start: 2018-06-22End: 2021-07-09Updated: 2022-09-06

Related Papers

Long-Term Safety and Efficacy of Obeticholic Acid in Patients With Primary Biliary Cholangitis: Final Results of the POISE Long-Term Safety Extension.

2026-07-14

Hepatic real-world outcomes with obeticholic acid in primary biliary cholangitis (HEROES): A trial emulation study design

Hepatology2024-12-049 citations

Obeticholic acid is associated with improvements in AST-to-platelet ratio index and GLOBE score in patients with primary biliary cholangitis

JHEP Reports2020-09-2916 citations

A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis.

2020-03-10149 citations

Long-Term Obeticholic Acid Therapy Improves Histological Endpoints in Patients With Primary Biliary Cholangitis.

2019-10-1065 citations

Long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis: 3-year results of an international open-label extension study.

2019-03-26138 citations

A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis

New England Journal of Medicine2016-08-171056 citations