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Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis — POISE  

Primary Biliary Cirrhosis Clinical Trial

Official title:
A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

Clinical Trial Summary

The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).

Clinical Trial Description

The study included 2 phases: a 12-month randomized, double-blind (DB), placebo-controlled, parallel group phase, followed by a long-term safety extension (LTSE) phase up to 5 years. Participants from the 12-month DB phase, including those who received placebo, were eligible to participate in the open-label LTSE phase. The Month 12 visit from the DB phase served as the Day 1 visit of the LTSE phase. After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA. Data for the LTSE phase is reported by the randomized dose group assigned in the DB phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01473524
Study type Interventional
Source Intercept Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date January 2012
Completion date December 17, 2018
View Details
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