Status:
COMPLETED
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HCV Infection
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 eff...
Detailed Description
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 po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00221624
Start Date
November 1 2001
End Date
April 1 2004
Last Update
June 13 2007
Active Locations (1)
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1
Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan
Pessac, France, 33604