Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV
Phase 3
Completed
- Conditions
- Liver Fibrosis
- Interventions
- Registration Number
- NCT01935817
- Lead Sponsor
- University of Catania
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Silybin + vitamin E + phospholipids complex Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months sugar pill Placebo one placebo pill per day for 12 months
- Primary Outcome Measures
Name Time Method transforming growth factor beta 12 months serum marker of liver fibrosis
- Secondary Outcome Measures
Name Time Method hyaluronic acid 12 months serum marker of liver fibrosis
Trial Locations
- Locations (1)
Cannizzaro Hospital
🇮🇹Catania, Sicily, Italy