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

- 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)
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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: | 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 |
Hepatitis C, Chronic Fibrosis Interferon Alfa-2b Ribavirin Prazosin |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Fibrosis 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 Interferon alpha-2 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 |