Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV

Phase 3CompletedNCT01935817

University of Catania64 enrolled

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-α2b plus Ribavirin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Liver Fibrosis

Interventions

Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complexDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older, * infection by HCV * under treatment with pegylated interferon 2 alpha and ribavirin Exclusion Criteria: * other liver diseases * cancer * severe jaundice * pulmonary and renal chronic diseases * prostatic diseases * autoimmune diseases * diabetes mellitus

Locations (1)

Cannizzaro Hospital

Catania, Sicily, Italy

Outcomes

Primary Outcomes

transforming growth factor beta

serum marker of liver fibrosis

Time frame: 12 months

Secondary Outcomes

hyaluronic acid

serum marker of liver fibrosis

Time frame: 12 months

Data from ClinicalTrials.gov

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