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Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients

NCT01518933 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-03-05

No results posted yet for this study

Summary

Hepatitis C virus (HCV)-related liver disease is the most common indication for liver transplantation (LT). However, LT does not cure the infection, and therapeutic strategies resulted in very limited efficacy and tolerability in LT recipients. In view of its postulated safety profile, Silibinin seems an ideal drug to be used in the setting of HCV recurrent patients after liver transplantation.

Conditions

  • Hepatitis C Virus Recurrence

Interventions

DRUG

Silibinin (Legalon-SIL)

20 mg/kg Silibinin (Legalon SIL), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.

DRUG

Saline

Placebo

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico

    collaborator OTHER

  • Rottapharm

    lead INDUSTRY

Principal Investigators

  • Alfredo Di Leo, MD · Azienda Ospedaliero-Universitaria Policlinico Consorziale - Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518933 on ClinicalTrials.gov