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.

Condition	Intervention	Phase
Hepatitis C, Chronic Fibrosis	Drug: Peg-interferon alpha 2b (drug)  Drug: Ribavirin (drug)  Drug: Prazosin (drug)	Phase II

Further Study Details: 

Primary Outcomes: 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)
Secondary Outcomes: Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96; Sustained virological response: undetectable HCV RNA at W96; Sustained biochemical response: ALT level at W96
Expected Total Enrollment:  112

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Chronic viral hepatitis C, genotype 1 or 4
• Fibrosis F3 or F3-F4, assessed by the scoring Metavir system
• Initial treatment against HCV

Exclusion Criteria:

• Psychiatric pathology
• Alcool consummation
• Pregnancy or plan of pregnancy
• Breastfeeding

Please refer to this study by ClinicalTrials.gov identifier  NCT00148837

WINNOCK Maria      00 33 5 57 57 45 39    maria.winnock@isped.u-bordeaux2.fr

France
      Hopital du haut Leveque, Pessac,  33604,  France; Recruiting

Study chairs or principal investigators

de Ledinghen Victor, MD, PhD,  Principal Investigator,  Hopital du Haut-Leveque, Service d''''Hepato-Gastroenterologie, Pessac 33604, France   
Chene Genevieve, MD, PhD,  Study Director,  INSERM Unite 593, Bordeaux, France   

Study ID Numbers:  2004-001326-24; ANRSHC17 Prazor
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00148837
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13