PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is a Phase III, multicenter, randomized, blinded, placebo-controlled trial to compare safety and efficacy of pegylated interferon a2a (PEG-2a) plus placebo vs. PEG-2a plus ribavirin (RV). It is a collaborative study by 11 university centers and the NIDDK. A total of 112 (and between 5 and 15 in Denver) children 5-18 years of age will be enrolled in the study. Enrolled patients will receive subcutaneous PEG-2a once a week given with placebo or RV tablet/s given orally once or twice daily, depending on the patient's weight for 48 (possibly up to 76) weeks. Patients will be randomized to PEG-2a plus placebo vs. PEG-2a plus RV in a 1:1(50:50) ratio by a computer-generated randomization scheme. Following the initiation of study drug, patients will return for evaluation at weeks 2, 4, 6, and 8, and then every 4 weeks thereafter, while receiving study drug therapy. Patients will be followed for approximately 2+ years after discontinuing study drug therapy. The primary efficacy outcome is non detectable serum HCV-RNA 24 weeks after the end of treatment. The primary safety outcomes are vital signs, laboratory tests and clinical adverse events. Secondary outcomes will include growth (height, weight, anthropometrics), body composition (DEXA, BIA) and quality-of-life assessment.