A Phase 2 interventional study of Peg-interferon alpha 2b + Ribavirin(drug) and Prazosin (drug) in Hepatitis C, Chronic and Fibrosis, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Phase 2, Interventional, and Treatment
Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.
Treatment of hepatitis C with interferon and ribavirin has a virological effect. Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. In vitro studies of prazosin suggest an effect against hepatic fibrosis, but the clinical effect of prazosin on the hepatic fibrosis induced by hepatitis C infection is unknown. The purpose of this multicentric national study is to compare the effects among the hepatic fibrosis of peg-interferon alpha 2b and ribavirin with prazosin or not (placebo). 112 patients with a viral hepatitis C, genotype 1 or 4, and severe fibrosis, will be randomly assigned to one of two treatment groups: peg-interferon alpha 2b and ribavirin, with prazosin or with placebo. Peg-interferon alpha 2b will be administered once a week (1.5 micro g per kg) during 48 weeks, ribavirin 1,000 to 1,200 mg per day (according to weight) during 48 weeks, prazosin/placebo 5 mg (2 pills) per day during 96 weeks. Evaluation will be done at 96 weeks. The primary end-point is the proportion of patients presenting a decrease of fibrosis. Secondary end-points are other criteria of histological response, virological response, biochemical response.
1,073 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 112 is above the median of 90 across 775 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 83 studies on the registry; none are open to participants now.
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Exclusion Criteria:
PegInterferon alfa-2b + Ribavirin + Prazosin
Drug: Peg-interferon alpha 2b + Ribavirin(drug) · Drug: Prazosin (drug)
PegInterféron alfa-2b + Ribavirin + placebo
Drug: Peg-interferon alpha 2b + Ribavirin(drug)
one to two capsules 2.5 mg per day
Proportion of patients presenting a decrease of fibrosis as measured on the liver biopsy and considered as clinically interesting (decrease of fibrosis pre- and post-therapeutic (W96) measures of at least 10 percent)
Time frame: W96
Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96
Time frame: W96
Sustained virological response: undetectable HCV RNA at W96
Time frame: W96
Sustained biochemical response: ALT level at W96
Time frame: W96
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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French National Agency for Research on AIDS and Viral Hepatitis