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OpenTrials
Completed

NCT Number: NCT01935817

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

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.

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Key information

Conditions

Liver Fibrosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cannizzaro Hospital

Catania, Sicily, 95125, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Placebo

Drug

Primary outcomes

  1. transforming growth factor beta

    Time frame: 12 months

    serum marker of liver fibrosis

Secondary outcomes

  1. hyaluronic acid

    Time frame: 12 months

    serum marker of liver fibrosis

Other outcomes

  1. metalloproteinase 2

    Time frame: 12 months

    serum marker of liver fibrosis

  2. amino-terminal pro-peptide of type III procollagen

    Time frame: 12 months

    serum marker of liver fibrosis

  3. tissue inhibitor of matrix metalloproteinase type I

    Time frame: 12 months

    serum marker of liver fibrosis

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 5, 2013
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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