NCT01535092

Legalon SIL for the Treatment of HCV Recurrence in Liver Transplanted Patients

A Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Legalon SIL for the Treatment of HCV Recurrence of the Graft in Orthotopic Liver Transplant Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Rottapharm · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Orthotopic liver transplantation (OLT) is the treatment of choice for patients with Hepatitis C Virus (HCV) infection and end-stage liver disease or hepatocellular carcinoma; infection of the graft and hepatitis C recurrence is universal after OLT and recurrent HCV hepatitis often follows an accelerated course after OLT, with rapid histological recurrence and cirrhosis. These very poor outcome significantly affect graft and patient survival and reduces the benefit of transplantation for this indication. Therapeutic strategies are not available; high viral load, high prevalence of genotype 1b and need of dose reduction of interferon and ribavirin because of the side effects or intolerance, together with the interference of immunosuppressive drugs, resulted in the vast majority of the patients in failure in obtaining viral eradication. Recently, Silibinin, has been studied and reported to be capable to act as potent antiviral agent in patients with HCV; it has been used successfully in a protocol of a 14 day intravenous infusion in previous non-responders to peginterferon/ribavirin therapy. In view of his postulated profile of safety, it seems an ideal drug to be used in the setting of HCV recurrent patients after liver transplant. Aim of this prospective, randomized, double-blind, placebo-controlled, parallel group study is to determine the therapeutic effect of Legalon SIL in the prevention of HCV reinfection in chronically infected hepatitis C patients after OLT. Awaiting orthotopic liver transplantation patients affected by HCV will be randomised 3:1 to receive, in addition to their current therapy, silibinin 20mg/kg/day (Legalon SIL) or placebo infused over 2 hours from 14 to 21 consecutive days; in addition, patients will receive treatment with silibinin 20mg/kg/day (Legalon SIL), infused over 2 hours, for 7 days after transplant. The Primary Efficacy endpoint is to achieve sustained virological response (SVR) while Secondary Efficacy endpoints are to evaluate the virologic response, the percentage of patients who has a decreased of at least 2 log10 the levels of HCV-RNA and the safety of Legalon SIL in this population.

Conditions

• HCV Recurrence After Liver Transplantation

Interventions

Type	Name	Description
DRUG	Silibinin	20mg/Kg daily by intravenous infusion, for 14-21 days pre-OLT and for 7 days post-OLT
DRUG	Placebo	Saline, daily infused for 14-21 days pre-OLT and for 7 days post-OLT

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2012-02-17
• Last updated: 2012-02-17