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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HCV Infection, Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Peginterferon alfa-2a
* Drug: ribavirin
* Drug: amantadine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Peginterferon alfa-2a|nan|
|Drug: ribavirin|nan|
|Drug: amantadine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT < upper limit of normal values, |  | 24 weeks after the end of anti-HCV treatment | 
| histological response according to METAVIR score |  | 24 weeks after the end of anti-HCV treatment | 
| adverse effects |  |  | 
| quality of life assessed |  | at week 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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