PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项在5-18岁慢性丙型肝炎儿童中进行的抗病毒治疗的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，将儿童以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）随机分配至2组之一。本研究的目的是回答，PEG-2a联合利巴韦林（RV）和PEG-2a单独治疗儿童慢性丙型肝炎病毒（CHC）的安全性和有效性如何？PEG-2a联合RV或PEG-2a单独治疗CHC儿童是否可导致更高的持续病毒学应答率？PEG-2a（伴或不伴RV）治疗对丙型肝炎儿童的体重指数、身体组成和线性生长有何影响？PEG-2a（伴或不伴RV）治疗儿童的短期和长期结局（包括健康相关生活质量、认知和发育功能以及心理社会功能和行为）如何表征？

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?