CLINICAL TRIAL: PEGYLATED INTERFERON RIBAVIRIN FOR CHILDREN WITH HCV PEDS-C

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 慢性丙型肝炎病毒-丙型肝炎病毒感染是一个全球健康问题，因为据估计全世界有1.7亿人受到影响。在美国，18岁以下或等于18岁的儿童人群中丙型肝炎病毒感染的流行率估计为0.1-0.2%，而成年人为1.8%。因此，在美国大约有15万名儿童和390万成年人慢性感染丙型肝炎病毒。丙型肝炎病毒感染的重要性在于它容易引起隐匿性的进行性肝损害。持续的病毒学应答是指在治疗完成24周后在血清中检测不到丙型肝炎病毒RNA，在接受常规干扰素单独治疗的儿童中，大约36%的儿童出现持续的病毒学应答，在接受常规干扰素和利巴韦林联合治疗的儿童中，大约50%的儿童发生持续病毒学应答。在成人中，基于聚乙二醇化干扰素的治疗方案比基于常规干扰素的治疗方案更好，但对儿童的聚乙二醇干扰素知之甚少。本研究的目的是评价聚乙二醇化干扰素α-2a单独或联合利巴韦林治疗儿童慢性丙型肝炎的疗效和安全性。

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. Chronic hepatitis C virus-HCV infection is a global health problem as it affects an estimated 170 million individuals worldwide. In the United States, the prevalence of HCV infection in the pediatric population, under or equal to 18 years old, is estimated to be 0.1-0.2 percent as compared to 1.8 percent in adults. Thus, there are approximately 150,000 children and 3.9 million adults chronically infected with HCV in the United States. The importance of HCV infection lies in its propensity to cause insidiously progressive liver damage. Sustained virologic response, defined by undetectable HCV RNA in serum 24 weeks after completion of treatment, occurs in approximately 36 percent of children treated with conventional interferon alone and in about 50 percent of those given conventional interferon in combination with ribavirin. Pegylated interferon-based treatment regimens are better than those based on conventional interferon in adults but little is known about peginterferons in children. The purpose of this study is to assess the efficacy and safety of peginterferon alfa-2a alone or in combination with ribavirin in pediatric patients with chronic hepatitis C.