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

NCT00148837 | Completed Phase 2

• 2 other identifiers: ANRS HC17 PRAZOR2004-001326-24
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic; Fibrosis

Keywords

Hepatitis C, Chronic; Fibrosis; Interferon Alfa-2b; Ribavirin; Prazosin

Outcome Measures

Primary Outcomes (1)

• 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)

  W96

Secondary Outcomes (3)

• Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96

  W96

• Sustained virological response: undetectable HCV RNA at W96

  W96

• Sustained biochemical response: ALT level at W96

  W96

Study Arms (2)

prazosin

EXPERIMENTAL

PegInterferon alfa-2b + Ribavirin + Prazosin

Drug: Peg-interferon alpha 2b + Ribavirin(drug); Drug: Prazosin (drug)

placebo

PLACEBO COMPARATOR

PegInterféron alfa-2b + Ribavirin + placebo

Drug: Peg-interferon alpha 2b + Ribavirin(drug)

Interventions

Prazosin (drug) DRUG

one to two capsules 2.5 mg per day

prazosin

Peg-interferon alpha 2b + Ribavirin(drug) DRUG

placebo; prazosin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Pfizer: collaborator

Study Sites (1)

Hopital du haut Leveque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis

Interventions

Prazosin; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• de Ledinghen Victor, MD, PhD

  Hopital du Haut-Leveque, Service d'Hepato-Gastroenterologie, Pessac 33604, France

  PRINCIPAL INVESTIGATOR

• Chene Genevieve, MD, PhD

  INSERM Unite 593, Bordeaux, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 15, 2026

Record last verified: 2008-02

Locations

FR (1)