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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

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ClinicalTrials.gov Identifier: NCT00148837
Recruitment Status : Unknown
Verified February 2008 by French National Agency for Research on AIDS and Viral Hepatitis.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : February 8, 2008
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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)

Secondary Outcome Measures :
  1. Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96
  2. Sustained virological response: undetectable HCV RNA at W96
  3. Sustained biochemical response: ALT level at W96

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Nadia Squalli/regulatory affairs, ANRS
ClinicalTrials.gov Identifier: NCT00148837     History of Changes
Other Study ID Numbers: 2004-001326-24
ANRSHC17 Prazor
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: February 2008

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Hepatitis, Chronic
 Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Prazosin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists