Liver Fibrosis
Conditions
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.
Interventions
DRUGSilybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex
DRUGPlacebo
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| transforming growth factor beta | 12 months | serum marker of liver fibrosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hyaluronic acid | 12 months | serum marker of liver fibrosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| metalloproteinase 2 | 12 months | serum marker of liver fibrosis |
| amino-terminal pro-peptide of type III procollagen | 12 months | serum marker of liver fibrosis |
| tissue inhibitor of matrix metalloproteinase type I | 12 months | serum marker of liver fibrosis |
Countries
Italy
Outcome results
None listed