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

Find a site near you

Start Over

Mercy Medical Center

Baltimore, MD United States
  Connect »

Kansas City Research Institute

Kansas City, MO United States
  Connect »

UPMC Center for Liver Diseases

Pittsburgh, PA United States
  Connect »

Nepean Hospital

Kingswood, Australia
  Connect »

University Of Michigan

Ann Arbor, MI United States
  Connect »

Higea S.A.

Mendoza, Argentina
  Connect »