Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic Impairment
Status:
Terminated
Trial end date:
2021-07-09
Target enrollment:
Participant gender:
Summary
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.