NCT00244751

Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects

A Double-Blind, Randomized, Placebo-Controlled Multi-Center, Phase II Parallel Dose-Ranging Study to Assess the Antifibrotic Activity of GI262570 in Chronic Hepatitis C Subjects With Hepatic Fibrosis Who Have Failed Prior Antiviral Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior treatment with interferon (either pegylated or standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but either failed to clear the virus or didn't tolerate the treatment.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
DRUG	GI262570 0.5 mg	GI262570 0.5 mg
DRUG	GI262570 1.0 mg	GI262570 1.0 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2005-11-02
• Primary completion: 2008-03-13
• Completion: 2008-03-13
• First posted: 2005-10-27
• Last updated: 2017-12-11
• Results posted: 2017-12-11

Locations

121 sites across 14 countries: United States, Australia, Canada, Czechia, Germany, Israel, Malaysia, New Zealand, Puerto Rico, Romania, Russia, Singapore, South Korea, Taiwan