Multi-center, Phase I, Randomized, Open-label, uncontrolled, parallel group, safety, tolerability, pharmacokinetic and pharmacodynamic study, in pediatric patients with compensated chronic hepatitis C. Background: Hepatitis C is a global infection which affects both adults and children. Based on the current epidemiology and clinical experience in the management of chronic hepatitis C, there is every reason to believe that the virus behaves the same way in pediatric patients as in adults. As the pathogenesis of hepatocellular damage is generally mediated by the host immune response to GI infection in the liver, pediatric patients may not be able to mount or sustain a strong immune response over years of HCV carriage as adults do. This in turn, results in fewer histologic features of liver damage. Pediatric HCV patients therefore resemble a subset of adult patients who are clinically asymptomatic, have a shorter duration of infection, less liver damage, and who typically have more favorable response to interferon therapy. Based on the demonstrated synergy of interferon alfa-2b and ribavirin in adult patients with chronic HCV, it is reasonable to assume that this treatment regimen will also benefit pediatric patients. The purpose of this study is to assess the safety and tolerability of Intron A plus ribavirin in pediatric patients with chronic hepatitis C.
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