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

Liver Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935817
• Other study ID #: unict11/1997
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2013
• Last updated: September 4, 2013
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Intervention

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

• Placebo

Locations

Country	Name	City	State
Italy	Cannizzaro Hospital	Catania	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	metalloproteinase 2	serum marker of liver fibrosis	12 months	Yes
Other	amino-terminal pro-peptide of type III procollagen	serum marker of liver fibrosis	12 months	Yes
Other	tissue inhibitor of matrix metalloproteinase type I	serum marker of liver fibrosis	12 months	Yes
Primary	transforming growth factor beta	serum marker of liver fibrosis	12 months	Yes
Secondary	hyaluronic acid	serum marker of liver fibrosis	12 months	Yes