drugset / Trial / NCT00550862

Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

NCT00550862

Phase 2 Terminated 165 enrolled Intercept Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.

Timeline

Start
2007-10
Primary completion
2009-08
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Obeticholic Acid Small molecule 10 mg Oral
Subject Obeticholic Acid Small molecule 25 mg Oral
Subject Obeticholic Acid Small molecule 50 mg Oral
Background Ursodeoxycholic Acid Small molecule

Indications