At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 217 enrolled
Drug / intervention
Obeticholic Acid (OCA) +1 moredrug
Likely dose
Obeticholic Acid (OCA) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
In Brief
A Phase 3 clinical trial evaluating Obeticholic Acid (OCA) and Placebo for Primary Biliary Cirrhosis. Completed, enrolled 217 participants across 59 sites in 13 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cirrhosis
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartJan 2012
Primary CompletionDec 2013
Study CompletionDec 2018
TodayJul 2026
First PostedNov 17, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2013
Study CompletionDec 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.6 years ago
Interventions
Obeticholic Acid (OCA)drug
OCA was administered orally once daily and provided in tablet form in 2 strengths: 5 mg and 10 mg.
Placebodrug
Matching placebo tablets were administered orally once daily.