The objective of this study is to assess the safety, tolerability, and effectiveness of the combination of Intron A and Ribavirin in pediatric patients diagnosed with chronic hepatitis C virus (HCV). The clinical features and evolution of the HCV infection are similar between adults and children, and pilot studies suggest that adults and children respond in a similar manner to treatment. Trials in the USA and Europe suggest 30-40% incidence of virus-free response with alpha-interferon and ribavirin treatment (combination therapy) in patients unresponsive to interferon therapy as well as in naive patients, compared to a 6-15% response rate in patients using interferon alone. This enhanced efficacy with the combination of Interferon plus ribavirin in adults provides a basis for its evaluation in children. The subjects of this study will all be pediatric patients between the ages of 5 and 16 years old, who have been diagnosed with chronic compensated liver disease caused specifically by the hepatitis C virus. Once a patient has been determined eligible for participation in a protocol for alpha-interferon and ribavirin treatment (combination therapy), he or she will be assigned by chance to one of three different study groups; all three groups, or arms, of the study will receive the same amount of IntronA, plus some differing amount of ribavirin. The treatment will include 3 million units of IntronA, taken by injection three times a week, plus either 8,15, or 12 mg/kg of ribavirin taken orally twice daily in divided doses. The quantity of the dose of ribavirin each patient receives will be determined by randomization, according to a computer-generated code. After the initial visit, patients will return to the clinic on weeks 2,4,6, and 8, and then they will only return every fourth week. The length of treatment in the study will last for 48 weeks (or until patient withdraws or is removed from the study for some reason), followed by a 24-week follow-up period.
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