Legalon SIL for the Treatment of HCV Recurrence in Liver Transplanted Patients
Status:
Terminated
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
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.