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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

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date February 8, 2008
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00148837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C, Chronic
  • Fibrosis
Intervention  ICMJE
  • Drug: Peg-interferon alpha 2b (drug)
  • Drug: Ribavirin (drug)
  • Drug: Prazosin (drug)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 7, 2005)
112
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00148837
Other Study ID Numbers  ICMJE 2004-001326-24
ANRSHC17 Prazor
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nadia Squalli/regulatory affairs, ANRS
Study Sponsor  ICMJE French National Agency for Research on AIDS and Viral Hepatitis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account French National Agency for Research on AIDS and Viral Hepatitis
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP