Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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 effective to treat hepatitis C.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Hoffmann-La Roche
• Treatments: Amantadine; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

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