At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
IDN-6556 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating IDN-6556 and Placebo for Liver Fibrosis and 3 related conditions. Completed, enrolled 64 participants across 35 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionFeb 2018
Study CompletionMar 2018
TodayJul 2026
First PostedMay 14, 2014
Enrollment StartMay 1, 2014
Primary CompletionFeb 15, 2018
Study CompletionMar 9, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.1 years ago
Interventions
IDN-6556drug
Placebodrug
Placebo control