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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
This study is ongoing, but not recruiting participants.
Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis
Information provided by: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00148837
  Purpose

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

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons Prazosin Prazosin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 112
Study Start Date: September 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148837

Locations
France
Hopital du haut Leveque
Pessac, France, 33604
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: de Ledinghen Victor, MD, PhD Hopital du Haut-Leveque, Service d'Hepato-Gastroenterologie, Pessac 33604, France
Study Director: Chene Genevieve, MD, PhD INSERM Unite 593, Bordeaux, France
  More Information

Responsible Party: ANRS ( Nadia Squalli/regulatory affairs )
Study ID Numbers: 2004-001326-24, ANRSHC17 Prazor
Study First Received: September 7, 2005
Last Updated: February 6, 2008
ClinicalTrials.gov Identifier: NCT00148837  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Hepatitis C, Chronic
Fibrosis
Interferon Alfa-2b
Ribavirin
Prazosin

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Liver Diseases
Hepatitis, Chronic
Fibrosis
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Prazosin
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neurotransmitter Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Adrenergic Antagonists
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009