Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients (PEGARI)
This study has been completed.
Sponsor:
University Hospital, Bordeaux
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221624
First received: September 13, 2005
Last updated: June 12, 2007
Last verified: June 2007
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Amantadine hydrochloride
Amantadine
Interferon
Ribavirin
Peginterferon Alfa-2a
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by University Hospital, Bordeaux:
Primary Outcome Measures:
- sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment (i.e. overall 72 weeks after randomization) [ Time Frame: 24 weeks after the end of antiHCV treatment ]
Secondary Outcome Measures:
- ALT < upper limit of normal values, [ Time Frame: 24 weeks after the end of anti-HCV treatment ]
- histological response according to METAVIR score [ Time Frame: 24 weeks after the end of anti-HCV treatment ]
- adverse effects
- quality of life assessed [ Time Frame: at week 72 ]
| 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 |
Criteria
Inclusion Criteria:
- Chronic hepatitis C
- Previously treated with a combination of interferon plus ribavirin for at least 24 weeks
- Detectable HCV RNA (i.e. non responders)
- Signed informed consent
Exclusion Criteria:
- Evidence of another cause of liver disease
- Liver cirrhosis (child-Pugh stage BMC)
- Alcohol consumption > 30g/day for women or > 40g/day for men ; drug abuse
- Other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221624
Locations
| France | |
| Service d’hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan | |
| Pessac, France, 33604 | |
Sponsors and Collaborators
University Hospital, Bordeaux
Hoffmann-La Roche
Investigators
| Principal Investigator: | Patrice Couzigou, Pr | University Hospital, Bordeaux |
| Study Chair: | Geneviève Chêne, Pr | University Hospital, Bordeaux |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00221624 History of Changes |
| Other Study ID Numbers: | 7929-01, 2000-030 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 12, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Bordeaux:
|
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 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Amantadine Interferons |
Ribavirin Peginterferon alfa-2a Interferon-alpha Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic |
ClinicalTrials.gov processed this record on June 17, 2013