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Trial record 8 of 179 for:    Phospholipids

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

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ClinicalTrials.gov Identifier: NCT01935817
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
Mariano Malaguarnera, University of Catania

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.


Condition or disease Intervention/treatment Phase
Liver Fibrosis Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


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



Primary Outcome Measures :
  1. transforming growth factor beta [ Time Frame: 12 months ]
    serum marker of liver fibrosis


Secondary Outcome Measures :
  1. hyaluronic acid [ Time Frame: 12 months ]
    serum marker of liver fibrosis


Other Outcome Measures:
  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



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935817


Locations
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Italy
Cannizzaro Hospital
Catania, Sicily, Italy, 95125
Sponsors and Collaborators
University of Catania

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Responsible Party: Mariano Malaguarnera, A.P., University of Catania
ClinicalTrials.gov Identifier: NCT01935817     History of Changes
Other Study ID Numbers: unict11/1997
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Silybin
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents