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Clinical Trial Summary

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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03633227
Study type Interventional
Source Intercept Pharmaceuticals
Contact
Status Terminated
Phase Phase 4
Start date June 22, 2018
Completion date July 9, 2021

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