CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Obeticholic Aciddrug
Likely dose
Obeticholic Acid 10 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.

Search/NCT01865812
NCT01865812Phase 2Completed
CompareCT.gov

A Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis

Intercept Pharmaceuticals·interventional·Posted May 31, 2013·Updated Aug 24, 2022

In Brief

A Phase 2 clinical trial evaluating Obeticholic Acid for Primary Biliary Cirrhosis. Completed, enrolled 27 participants across 7 sites.

Detailed Summary

The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cirrhosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 31, 2013
Enrollment StartDec 3, 2013
Primary CompletionAug 13, 2014
Study CompletionSep 12, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.1 years ago

Interventions

Obeticholic Aciddrug

All participants were treated with OCA (oral administration, 10 mg, once daily \[QD\]) for 8 weeks and continued their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8-week Primary Treatment Phase of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter an open-label, long-term safety extension phase, during which they could receive 10 mg OCA QD for up to 2 years.