Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

Study Overview
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Brief Summary
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* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

Detailed Description
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The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1). Viral load will not be a discriminating factor. The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.

Official Title
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Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Amantadine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anti-HCV positivity >6 months ALT and/or AST elevation on at least once in the previous 6 months Positive HCV-RNA Liver biopsy within one year before the start of therapy in non- cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary Intention to be treated and participate treatment Obtained written informed consent Exclusion Criteria: Age < 18 years Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy Life expectancy < 1 year Child Pugh B or C (Appendix III) Creatinine > 150 μmol/L or > 1.70 mg/dl Haemoglobulin < 6.5 mmol/l or < 10.5 g/dl White blood cell count < 2,5 x 109/L, neutrophil < 1,5 x 109/L Platelet count < 70 x 109/L HIV positivity Chemotherapy, systematical antiviral treatment during the 6 months prior to study entry Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias) Active uncontrolled psychiatric disorders and suicidal leanings Patients with a history of uncontrolled seizure or other significant CNS dysfunction Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives

Ages Eligible for Study
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Minimum Age: 18 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: Amantadine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate at end of treatment and end of follow-up (sustained response rate) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, Amantadine, Triple therapy