PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

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。 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，这些儿童将按1：1的比例(聚乙二醇化干扰素+利巴韦林与聚乙二醇2a+安慰剂)随机分为两组之一。 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)和单独使用聚乙二醇α-2a治疗儿童慢性丙型肝炎病毒(HCV)的安全性和有效性是什么？在丙型肝炎病毒感染的儿童中，聚乙二醇2a联合RV或单独使用聚乙二醇2a是否会导致更高的持续病毒学应答率？在丙型肝炎病毒携带者中，聚乙二醇2a(伴随或不伴随RV)治疗对体重指数、身体成分和线性生长有什么影响？接受聚乙二醇2a(伴随或不伴随RV)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、认知和发展功能，以及心理社会功能和行为是如何表征的？ 入选的患者将接受每周一次的聚乙二醇2a皮下注射，同时给予安慰剂或RV片剂/S每天口服两次。患者将接受24-48周的治疗，这取决于他们被随机分配到哪个治疗臂，以及他们对治疗药物的反应。所有患者在停止研究药物后将被密切跟踪24周，并在长期随访期内每年随访2次。

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 (HCV) in children? Does PEG-2a in combination with RV or PEG-2a alone result in a higher sustained virologic response rate in children with HCV? 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 HCV? 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? Enrolled patients will receive a subcutaneous PEG-2a injection once a week given with placebo or RV tablet/s given orally twice daily. Patients will be treated for 24-48 weeks depending on which treatment arm they are randomized to, and their response to treatment drug. All patients will be followed closely for 24 weeks after discontinuation of study drug and will have 2 annual visits during the long-term follow-up period.