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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00148837
Other study ID # 2004-001326-24
Secondary ID ANRSHC17 Prazor
Status Active, not recruiting
Phase Phase 2
First received September 7, 2005
Last updated February 6, 2008
Start date September 2004

Study information

Verified date February 2008
Source French National Agency for Research on AIDS and Viral Hepatitis
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 112
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Peg-interferon alpha 2b (drug)

Ribavirin (drug)

Prazosin (drug)


Locations

Country Name City State
France Hopital du haut Leveque Pessac

Sponsors (1)

Lead Sponsor Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96
Secondary Sustained virological response: undetectable HCV RNA at W96
Secondary Sustained biochemical response: ALT level at W96
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