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
Recruitment status was Active, not recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 7, 2005 | ||||||||
| Last Updated Date | February 6, 2008 | ||||||||
| Start Date ICMJE | September 2004 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 112 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00148837 | ||||||||
| Other Study ID Numbers ICMJE | 2004-001326-24, ANRSHC17 Prazor | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| 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 |
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| Information Provided By | French National Agency for Research on AIDS and Viral Hepatitis | ||||||||
| Verification Date | February 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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