search
Back to results

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

Primary Purpose

Liver Fibrosis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex
Placebo
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Fibrosis

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cannizzaro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Silybin + vitamin E + phospholipids complex

sugar pill

Arm Description

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

one placebo pill per day for 12 months

Outcomes

Primary Outcome Measures

transforming growth factor beta
serum marker of liver fibrosis

Secondary Outcome Measures

hyaluronic acid
serum marker of liver fibrosis

Full Information

First Posted
September 1, 2013
Last Updated
September 4, 2013
Sponsor
University of Catania
search

1. Study Identification

Unique Protocol Identification Number
NCT01935817
Brief Title
Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silybin + vitamin E + phospholipids complex
Arm Type
Active Comparator
Arm Description
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
one placebo pill per day for 12 months
Intervention Type
Drug
Intervention Name(s)
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
transforming growth factor beta
Description
serum marker of liver fibrosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
hyaluronic acid
Description
serum marker of liver fibrosis
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
metalloproteinase 2
Description
serum marker of liver fibrosis
Time Frame
12 months
Title
amino-terminal pro-peptide of type III procollagen
Description
serum marker of liver fibrosis
Time Frame
12 months
Title
tissue inhibitor of matrix metalloproteinase type I
Description
serum marker of liver fibrosis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cannizzaro Hospital
City
Catania
State/Province
Sicily
ZIP/Postal Code
95125
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs