Hepatitis C, Chronic Clinical Trial
— PEGARIOfficial 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
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.
Status | Completed |
Enrollment | 131 |
Est. completion date | April 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Service d’hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Hoffmann-La Roche |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 24 weeks after the end of antiHCV treatment | ||
Secondary | ALT < upper limit of normal values, | 24 weeks after the end of anti-HCV treatment | ||
Secondary | histological response according to METAVIR score | 24 weeks after the end of anti-HCV treatment | ||
Secondary | adverse effects | |||
Secondary | quality of life assessed | at week 72 |
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