PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目标包括：1.评估聚乙二醇化干扰素α-2a(PEG-2a)联合利巴韦林(RV)和单独使用聚乙二醇-2a治疗儿童慢性丙型肝炎病毒(CHC)感染的安全性和有效性。II.确定聚乙二醇2a联合RV或单独使用聚乙二醇2a是否会导致慢性丙型肝炎儿童的持续病毒学应答率更高。研究聚乙二醇2a(合并或不合并轮状病毒)治疗对感染丙型肝炎的儿童的体重指数、身体成分和线性生长的影响。研究接受聚乙二醇2a(合并或不合并轮状病毒)治疗的儿童的短期和长期结果，包括与健康相关的生活质量(QOL)、认知发育和心理功能以及行为。这项为期5年的研究将招募112名5-18岁感染丙型肝炎的儿童，这些儿童将从全美11个参与中心招募。儿童将被随机分为单独接受PEG2a或PEG2a和利巴韦林联合治疗的组。治疗时间从48周到100周不等，具体取决于儿童对治疗的反应。单独对PEG2a无效的儿童将在第24周切换到联合治疗组。在治疗阶段结束后，有20周的未治疗随访期，以及此后两年的年度访问。

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. The goals of this study include: I. To assess the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children. II. To determine whether PEG-2a in combination with RV or PEG-2a alone will result in a higher sustained virologic response rate in children with CHC. III. To examine the effects of PEG-2a (with or without concomitant RV) treatment on body mass index, body composition, and linear growth in children infected with hepatitis C. IV. To characterize short- and long-term outcomes, including health-related Quality of Life (QOL), cognitive and developmental and psychological functioning, and behavior in children treated with PEG-2a (with or without concomitant RV). This 5 year study will enroll 112 children between the ages of 5-18 who are infected with hepatitis C. The children will be enrolled from 11 participating centers across the United States. Children will be randomized into groups that receive PEG 2a alone or a combination of PEG 2a and ribavirin. Treatment duration can range from 48 weeks up to 100 weeks depending on how the child responds to treatment. Children who do not respond to PEG 2a alone will be switched to the combination therapy group at week 24. Following completion of the treatment phase, there is a 20 week untreated follow-up period as well as annual visits for the next 2 years thereafter