At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 77 enrolled
Drug / intervention
Obeticholic Acid (OCA) +1 moredrug
Likely dose
Not stated in 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 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Primary Sclerosing Cholangitis
In Brief
A Phase 2 clinical trial evaluating Obeticholic Acid (OCA) and Placebo for Primary Sclerosing Cholangitis (PSC). Completed, enrolled 77 participants across 36 sites in 2 countries.
Detailed Summary
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE) phase was conducted to evaluate the safety, tolerability, and efficacy of long-term, open-label use of OCA in participants with PSC who had completed the DB phase of the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sclerosing Cholangitis (PSC)
CountriesItaly, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartFeb 2015
Primary CompletionMar 2017
Study CompletionMar 2018
TodayJul 2026
First PostedJun 27, 2014
Enrollment StartFeb 9, 2015
Primary CompletionMar 7, 2017
Study CompletionMar 22, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.0 years ago
Interventions
Obeticholic Acid (OCA)drug
Placebodrug