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。这是一项针对5-18岁慢性丙型肝炎儿童的抗病毒治疗的III期多中心随机安慰剂对照试验。根据计算机生成的随机代码，儿童将按1:1的比例（PEG-2a（聚乙二醇化干扰素）+利巴韦林vs PEG 2a +安慰剂）随机分为两组。本研究的目的是回答，聚乙二醇干扰素α -2a （peg -2a）联合利巴韦林（RV）和单独peg -2a治疗儿童慢性丙型肝炎病毒（CHC）的安全性和有效性是什么？PEG-2a联合RV还是单独使用PEG-2a在CHC儿童中产生更高的持续病毒学应答率？PEG-2a（合并或不合并RV）治疗对丙型肝炎儿童的体重指数、身体成分和线性生长有什么影响？接受PEG-2a治疗（伴或不伴RV）的儿童的短期和长期结果（包括健康相关的生活质量、认知和发育功能、社会心理功能和行为）是如何表征的？

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 is a phase III multicenter, randomized placebo-controlled trial of antiviral therapy, in children 5-18 years of age with chronic hepatitis C. The children will be randomized to one of the 2 groups in a 1:1 ratio (PEG-2a (pegylated interferon) + Ribavirn vs. PEG 2a + placebo) according to a computer generated random code. The purpose of this research is to answer, what are the safety and efficacy of peg interferon alfa-2a (PEG-2a) in combination with ribavirn (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) in children? Does PEG-2a in combination with RV or PEG-2a alone result in a higher sustained virologic response rate in children with CHC? What are the effects of PEG-2a (with or without concomitant RV) treatment on body mass index, body composition, and linear growth in children with hepatitis C? And how are the short and long term outcomes, including health-related quality of life, cognitive and developmental functioning, and psychosocial functioning and behavior in children treated with PEG-2a (with or without concomitant RV) characterized?