Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
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.
Timeline
- Start
- 2005-11-02
- Primary completion
- 2008-03-13
- Completion
- 2008-03-13
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs GI262570 0.5mg; p = 0.3608; reduced regression model NCT00244751 ↗
registry analysis (superiority or other test); Placebo vs GI262570 1.0mg; p = 0.3575; reduced regression model NCT00244751 ↗
registry analysis (superiority or other test); Placebo vs GI262570 0.5 mg; p = 0.9157; reduced regression model NCT00244751 ↗
registry analysis (superiority or other test); Placebo vs GI262570 1.0 mg; p = 0.9501; reduced regression model NCT00244751 ↗
registry analysis (superiority or other test); Placebo vs GI262570 0.5mg vs GI262570 1.0mg; p = 0.6483; Cochran-Mantel-Haenszel Test NCT00244751 ↗
registry analysis (superiority or other test); Placebo vs GI262570 0.5mg vs GI262570 1.0mg; p = 0.1776; Cochran-Mantel-Haenszel Test NCT00244751 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FARGLITAZAR | Small molecule | 0.5 mg | — |
| Subject | FARGLITAZAR | Small molecule | 1 mg | — |