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

University of Catania

Status and phase: Completed; Phase 3

Conditions: Liver Fibrosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01935817

unict11/1997

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Silybin + vitamin E + phospholipids complex

Active Comparator group

Description:

Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months

Treatment:

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

sugar pill

Placebo Comparator group

Description:

one placebo pill per day for 12 months

Treatment:

Drug: Placebo