NCT01473524

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Obeticholic Acid (OCA)	OCA was administered orally once daily and provided in tablet form in 2 strengths: 5 mg and 10 mg.
DRUG	Placebo	Matching placebo tablets were administered orally once daily.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2018-12-17
• First posted: 2011-11-17
• Last updated: 2021-05-06
• Results posted: 2017-02-13

Locations

59 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom