This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Hepatitis C is a significant cause of liver disease worldwide, affecting approximately 0.2-0.4% of children in the US. Since the disease can cause end-stage liver disease as well, finding effective therapy is critical. This study is a multicenter, randomized, placebo-controlled study comparing safety and efficacy of pegylated interferon monotherapy with pegylated interferon/ribavirin combination therapy for the treatment of hepatitis C in children. Children between ages 5 and 18 years will be enrolled and randomized (1:1) to receive weekly pegylated interferon injections and either ribavirin or placebo. Patients will be monitored closely during treatment. At 24 weeks, patients receiving combination therapy with ribavirin who remain positive for virus will be stopped from drug and considered treatment failures. Patients receiving peginterferon monotherapy or combination therapy who are negative for HCV (responders) at 24 weeks continue to complete 48 weeks of therapy. Patients on placebo and interferon who remain HCV-positive at 24 weeks cross over into a compassionate arm, receiving both peginterferon and ribavirin. These patients receive 48 weeks of combination therapy if they are HCV negative at 24 weeks; they discontinue therapy if they remain viremic at 24 weeks of combination therapy. All patients are followed for 2.5 years after completing treatment.
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