NCT00570765

Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study included 2 phases: a 3-month randomized, double-blind (DB), placebo-controlled, parallel group phase, followed by a long-term safety extension (LTSE). The planned duration of the LTSE phase was country-specific, ranging from 108 months to indefinitely. On-site visits occurred at least every 6 months. Following completion of the 3-month DB phase, participants who continued to meet protocol requirements were given the opportunity to enroll in the LTSE phase of the study at selected study sites. The participants who enrolled in the LTSE phase started OCA administration, from a starting dose (10 or 50 milligrams \[mg\]) based on the dose of OCA or placebo received in the DB phase or on the timing of entry into the LTSE phase. Because the LTSE phase was not planned in the original study design, participants had varied gaps between the end of the DB phase and the start of the LTSE phase. Moreover, some participants initiated ursodeoxycholic acid during the course of that break.

Conditions

• Liver Cirrhosis, Biliary

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo tablets were administered orally once daily.
DRUG	Obeticholic Acid (OCA)	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.

Timeline

• Start date: 2008-01-17
• Primary completion: 2010-09-21
• Completion: 2017-09-25
• First posted: 2007-12-11
• Last updated: 2021-06-22
• Results posted: 2011-07-07

Locations

21 sites across 7 countries: United States, Austria, Canada, France, Germany, Spain, United Kingdom