Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis

in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV

Status: Completed
Study Phase: Phase 3
Start Date: June 2010|Completion Date: December 2012
Condition(s): Liver Fibrosis
Overview
Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting
mainly from the complications of cirrhosis and HCC. The investigators' aim will be to
evaluate the impact on of supplementation with a new pharmaceutical complex of
silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with
Pegylated-Interferon-2b plus Ribavirin.

Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator,
Outcomes Assessor), Primary Purpose: Treatment

Investigator Details
Lead Sponsor: University of Catania

Trial Location Details

Facility: Cannizzaro Hospital Catania, Italy

Interventions

Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex

Drug: Placebo

Information Source
ID Number: unict11/1997
NCT Identifier: NCT01935817
Health Authority: Italy: Ethics Committee
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01935817
ClinicalTrials.gov processed this data on October 30, 2015
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