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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by French National Agency for Research on AIDS and Viral Hepatitis.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00148837
First received: September 7, 2005
Last updated: February 6, 2008
Last verified: February 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Nadia Squalli/regulatory affairs, ANRS
ClinicalTrials.gov Identifier: NCT00148837     History of Changes
Other Study ID Numbers: 2004-001326-24, ANRSHC17 Prazor
Study First Received: September 7, 2005
Last Updated: February 6, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Prazosin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014