Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Change from baseline in liver biopsy immunohistochemical markers. Change from baseline in fibrosis in liver biopsy. Histological assessment of paired biopsies (baseline and Week 52). Safety and tolerability of two doses of GI262570. [ Time Frame: 52 Weeks ]
- Proportion of subjects progressing at least 1 point in fibrosis score. Proportion of subjects regressing at least 1 point in fibrosis score. Change from baseline in markers of liver fibrosis. [ Time Frame: 12 Weeks ]
- ·Proportion of subjects progressing at least 1 point on the Ishak fibrosis score at Week 52 on each arm of the study. Progression is defined as an increase of at least one point in the fibrosis score.
- ·Proportion of subjects regressing at least 1 point on the Ishak fibrosis score at Week 52 on each arm of the study.
- ·Proportion of subjects whose Ishak fibrosis score remains unchanged at Week 52 on each arm of the study.
- ·Change from baseline in total Ishak Score (necroinflammatory score and fibrosis score) at Week 52.
- ·Change from baseline in Metavir scores.
- ·Change from baseline in serum FibroSure (FibroTest/ActiTest) score.
- ·Change from baseline in serum ALT levels.
- ·Change from baseline in measures of insulin resistance.
- ·Median serum ALT over time.
- ·Change from baseline in serum HCV RNA levels.
- ·Median serum HCV RNA levels over time.
- ·Pharmacokinetic measures:
- ·GI262570 serum PK parameters on Week 2 in a subset of subjects.
- ·GI262570 serum concentrations on Week 2, 16, 28, 40, and Week 52.
|Study Start Date:||November 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244751
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|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|