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

September 4, 2013 updated by: Mariano Malaguarnera, University of Catania

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Sicily
      • Catania, Sicily, Italy, 95125
        • Cannizzaro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silybin + vitamin E + phospholipids complex
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months
Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex
Placebo Comparator: sugar pill
one placebo pill per day for 12 months
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transforming growth factor beta
Time Frame: 12 months
serum marker of liver fibrosis
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hyaluronic acid
Time Frame: 12 months
serum marker of liver fibrosis
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
metalloproteinase 2
Time Frame: 12 months
serum marker of liver fibrosis
12 months
amino-terminal pro-peptide of type III procollagen
Time Frame: 12 months
serum marker of liver fibrosis
12 months
tissue inhibitor of matrix metalloproteinase type I
Time Frame: 12 months
serum marker of liver fibrosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 1, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • unict11/1997

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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