CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Obeticholic Acid (OCA) 50 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/NCT00570765
NCT00570765Phase 2Completed
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A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

Intercept Pharmaceuticals·interventional·Posted Dec 11, 2007·Updated Jun 22, 2021

In Brief

A Phase 2 clinical trial evaluating Placebo and Obeticholic Acid (OCA) for Liver Cirrhosis, Biliary. Completed, enrolled 60 participants across 21 sites in 7 countries.

Detailed Summary

The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cirrhosis, Biliary
CountriesAustria, Canada, France, Germany, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2007
Enrollment StartJan 17, 2008
Primary CompletionSep 21, 2010
Study CompletionSep 25, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.6 years ago

Interventions

Placebodrug

Matching placebo tablets were administered orally once daily.

Obeticholic Acid (OCA)drug

Starting dose of 10 or 50 mg administered orally once daily, followed by dose titration planned from 10 mg to 25 mg to 50 mg once daily, which could be modified for safety and tolerability issues or to achieve adequate therapeutic response.