A Phase 3 interventional study of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex and Placebo in Liver Fibrosis, sponsored by University of Catania. Completed at 1 site in Italy. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-09-05.
Sponsored by University of Catania · Phase 3, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 64 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Catania is the lead sponsor of 68 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
one placebo pill per day for 12 months
Drug: Placebo
transforming growth factor beta
serum marker of liver fibrosis
Time frame: 12 months
hyaluronic acid
serum marker of liver fibrosis
Time frame: 12 months
metalloproteinase 2
serum marker of liver fibrosis
Time frame: 12 months
amino-terminal pro-peptide of type III procollagen
serum marker of liver fibrosis
Time frame: 12 months
tissue inhibitor of matrix metalloproteinase type I
serum marker of liver fibrosis
Time frame: 12 months
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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University of Catania