Clinical trial NCT00148837: Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
Official title: Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Fibrosis
Keywords: Hepatitis C, Chronic
Fibrosis
Interferon Alfa-2b
Ribavirin
Prazosin
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2005-09-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: 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:
measure: Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96
measure: Sustained virological response: undetectable HCV RNA at W96
measure: Sustained biochemical response: ALT level at W96
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hopital du haut Leveque
Study officials:
affiliation: Hopital du Haut-Leveque, Service d'Hepato-Gastroenterologie, Pessac 33604, France
name: de Ledinghen Victor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM Unite 593, Bordeaux, France
name: Chene Genevieve, MD, PhD
role: STUDY_DIRECTOR
References: