At a glance
ClinicalIndex Comparison Record- ✓Age 40-70 years inclusive
- ✓HCV antibody positive (second generation or higher assay) and HCV RNA positive with genotype 1
- ✓Ishak fibrosis score of 2, 3, or 4
- ✓Prior treatment failure with interferon (standard or pegylated) and ribavirin at minimum dose 3mU three times weekly for at least 12 weeks, discontinued at least 11 months prior to biopsy
- ✕History of ascites, variceal hemorrhage, hepatic encephalopathy, spontaneous bacterial peritonitis, or other signs of hepatic decompensation
- ✕Evidence of ischemic heart disease or other cardiovascular disease that may adversely impact safety
- ✕NYHA Functional Class 1, 2, 3, or 4 cardiac status
- ✕HBV or HIV co-infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GI262570 0.5 mg, GI262570 1.0 mg, and 1 other intervention for Cirrhosis, Liver. Completed, enrolled 265 participants across 121 sites in 14 countries.
Detailed 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.
Study Details
Timeline
Interventions
GI262570 0.5 mg
GI262570 1.0 mg
Placebo