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Sponsored by: |
French National Agency for Research on AIDS and Viral Hepatitis |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00148837 |
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 |
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Hepatitis C, Chronic Fibrosis |
Drug: Peg-interferon alpha 2b (drug) Drug: Ribavirin (drug) Drug: Prazosin (drug) |
Phase II |
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 |
Enrollment: | 112 |
Study Start Date: | September 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Hopital du haut Leveque | |
Pessac, France, 33604 |
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 |
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 |
Hepatitis C, Chronic Fibrosis Interferon Alfa-2b Ribavirin Prazosin |
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 |
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 |