A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV

Summary

This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the new liver caused by HCV.

Timeline

Start

2014-05

Primary completion

2018-02-15

Completion

2018-03-09

Outcome

Missed primary endpoint

registry analysis (superiority test); IDN-6556 vs Placebo; p = 0.73; Risk Difference (RD) 2.9 (95% CI -20.5 to 26.4) NCT02138253 ↗

Drugs

Indications