NCT02138253

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

A Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects Who Had Hepatitis C Virus (HCV) Reinfection and Liver Fibrosis Following Orthotopic Liver Transplantation for Chronic HCV Infection and Who Subsequently Achieved a Sustained Virologic Response Following Anti-HCV Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There are data to suggest that with eradication of the HCV virus, improvements in liver fibrosis can be seen in the post-transplant population. However, amelioration of inflammatory activity, and deceleration of fibrosis progression is a gradual process over the course of many years. This placebo-controlled study is designed to evaluate the effects of IDN-6556, compared to placebo, on markers of apoptosis and inflammation, and liver histology.

Conditions

• Liver Fibrosis
• Hepatic Fibrosis
• Liver Cirrhosis
• Hepatic Cirrhosis

Interventions

Type	Name	Description
DRUG	IDN-6556
DRUG	Placebo	Placebo control

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-02-15
• Completion: 2018-03-09
• First posted: 2014-05-14
• Last updated: 2019-12-11
• Results posted: 2019-12-11

Locations

35 sites across 1 country: United States