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

  • STATUS
    Not Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    50
  • sponsor
    Intercept Pharmaceuticals
Updated on 12 May 2021
Investigator
Judith Romano
Primary Contact
Universitatsklinikum Leipzig AoR (0.9 mi away) Contact
+46 other location
platelet count
liver disease
cirrhosis
acute liver failure
liver failure
ursodiol
obeticholic acid
antimitochondrial antibody
glutaric acid

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.

Details
Condition Primary biliary cirrhosis, Primary Biliary Cholangitis
Treatment Placebo, Obeticholic Acid (OCA)
Clinical Study IdentifierNCT03633227
SponsorIntercept Pharmaceuticals
Last Modified on12 May 2021

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