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

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

Outcome

Met primary endpoint

Stopped: “Study stopped by sponsor due to administrative reasons”

paper OCA was superior to placebo in achieving the primary end point. PMID 25500425 ↗

registry analysis (other test); Obeticholic Acid (OCA) 10 Milligrams (mg) vs Placebo; p <0.0001; Wilcoxon (Mann-Whitney); NCT00550862 ↗

Publications

Hirschfield GM, Mason A, Luketic V, Lindor K, Gordon SC, Mayo M, Kowdley KV, Vincent C, Bodhenheimer HC Jr, Pares A, Trauner M, Marschall HU, Adorini L, Sciacca C, Beecher-Jones T, Castelloe E, Bohm O, Shapiro D. Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. Gastroenterology. 2015 Apr;148(4):751-61.e8. doi: 10.1053/j.gastro.2014.12.005. Epub 2014 Dec 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
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	—	—