NCT03633227

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis, Biliary

Interventions

Type	Name	Description
DRUG	Obeticholic Acid (OCA)	OCA will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	OCA matching placebo will be administered per the schedule specified in the arm description.

Timeline

• Start date: 2018-06-22
• Primary completion: 2021-07-09
• Completion: 2021-07-09
• First posted: 2018-08-16
• Last updated: 2022-09-06
• Results posted: 2022-09-06

Locations

40 sites across 12 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Estonia, Germany, Hungary, Italy, Lithuania, Spain

Regulatory

• FDA-regulated drug study