PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的包括：1 .评价聚乙二醇干扰素α -2a （PEG-2a）联合利巴韦林（RV）和单独使用PEG-2a治疗儿童慢性丙型肝炎病毒（CHC）感染的安全性和有效性。2。确定PEG-2a联合RV或单独使用PEG-2a是否会导致CHC儿童更高的持续病毒学应答率。3。研究PEG-2a（伴或不伴RV）治疗对丙型肝炎感染儿童体重指数、身体组成和线性生长的影响。表征短期和长期结局，包括与健康相关的生活质量（QOL）、认知、发育和心理功能，以及接受PEG-2a（伴或不伴RV）治疗儿童的行为。这项为期5年的研究将招募112名年龄在5-18岁之间的丙型肝炎感染儿童，这些儿童将来自美国11个参与中心。儿童将被随机分为单独接受PEG 2a或PEG 2a联合利巴韦林的组。治疗持续时间从48周到100周不等，这取决于儿童对治疗的反应。单独对PEG 2a无反应的患儿将在第24周转入联合治疗组。在治疗阶段结束后，有一个20周的未治疗随访期，以及此后2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