Last updated on May 2020

Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic Impairment

Brief description of study

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the PK and safety of OCA treatment in patients with primary biliary cholangitis (PBC) and moderate to severe hepatic impairment over a 48 week treatment period. Patients who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized patients have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all patients receive OCA will be considered following review of blinded safety and PK data.

Clinical Study Identifier: NCT03633227

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Mercy Medical Center

Baltimore, MD United States
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Kansas City Research Institute

Kansas City, MO United States
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UPMC Center for Liver Diseases

Pittsburgh, PA United States
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Nepean Hospital

Kingswood, Australia
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University Of Michigan

Ann Arbor, MI United States
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Higea S.A.

Mendoza, Argentina
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