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| Sponsors and Collaborators: |
University Hospital, Bordeaux Hoffmann-La Roche |
|---|---|
| Information provided by: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00221624 |
Purpose
Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.
| Condition | Intervention | Phase |
|---|---|---|
|
HCV Infection Hepatitis C, Chronic |
Drug: Peginterferon alfa-2a Drug: ribavirin Drug: amantadine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Interferon and Ribavirin |
| Enrollment: | 131 |
| Study Start Date: | November 2001 |
| Study Completion Date: | April 2004 |
Background : Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C. Design : randomized, double-blind, multicenter trial.
Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus Peg-interferon alfa 2A + ribavirin + Placebo
Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable HCV RNA.
primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Service d’hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan | |
| Pessac, France, 33604 | |
| Principal Investigator: | Patrice Couzigou, Pr | University Hospital, Bordeaux |
| Study Chair: | Geneviève Chêne, Pr | University Hospital, Bordeaux |
More Information
| Study ID Numbers: | 7929-01, 2000-030 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00221624 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Hepatitis C, chronic HCV infection Treatment failure PEG Interferon (Interferons/therapeutic use Interferon Alfa-2a/adverse effects) |
ribavirin (Ribavirin/therapeutic use Ribavirin/adverse effects) Amantadine Drug Therapy, Combination |
|
Antimetabolites Interferon-alpha Anti-Infective Agents Neurotransmitter Agents Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human Angiogenesis Inhibitors Antiviral Agents Hepatitis |
Virus Diseases Dopamine Digestive System Diseases Analgesics, Non-Narcotic Peginterferon alfa-2a Dopamine Agents Peripheral Nervous System Agents Analgesics Hepatitis C Amantadine Interferon Alfa-2a Hepatitis C, Chronic |
|
Antimetabolites Anti-Infective Agents Liver Diseases Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Flaviviridae Infections Antineoplastic Agents Anti-Dyskinesia Agents Physiological Effects of Drugs Ribavirin Hepatitis, Viral, Human Antiparkinson Agents Infection Sensory System Agents |
Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Analgesics Hepatitis C RNA Virus Infections Growth Substances Interferons Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Analgesics, Non-Narcotic |
