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

NCT ID: NCT01935817

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Liver Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Silybin + vitamin E + phospholipids complex

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

Group Type ACTIVE_COMPARATOR

Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex

Intervention Type DRUG

sugar pill

one placebo pill per day for 12 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Mariano Malaguarnera

A.P.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cannizzaro Hospital

Catania, Sicily, Italy

Site Status

Countries

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Italy

Other Identifiers

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unict11/1997

Identifier Type: -

Identifier Source: org_study_id