PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

聚乙二醇化干扰素/利巴韦林治疗丙型肝炎儿童

• 批准号: 7603530
• 负责人: KAREN F MURRAY
• 金额: $ 0.87万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603530
• 关键词: Age-Years; Antiviral Therapy; Behavior; Body Composition; Body mass index; Child; Chronic; Chronic Hepatitis C; Code; Cognitive; Computer Retrieval of Information on Scientific Projects Database; Daily; Development; Enrollment; Funding; Grant; Growth; Hepatitis C virus; Injection of therapeutic agent; Institution; Interferon Alfa-2a; Interferons; Outcome; Patients; Pharmaceutical Preparations; Phase; Placebos; Purpose; Randomized; Rate; Research; Research Personnel; Resources; Ribavirin; Safety; Source; Tablets; United States National Institutes of Health; Upper arm; Visit; Week; computer generated; discontinuation trial; follow-up; health related quality of life; peginterferon alfa-2a; psychosocial; randomized placebo controlled trial; response; subcutaneous

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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，聚乙二醇干扰素α-2a（PEG-2a）联合利巴韦林（RV）与单用PEG-2a治疗儿童慢性丙型肝炎病毒（HCV）的安全性和有效性如何？ PEG-2a联合RV或单独PEG-2a是否导致HCV儿童的持续病毒学应答率更高？ PEG-2a（伴或不伴RV）治疗对HCV患儿的体重指数、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？ 入组的患者将接受PEG-2a皮下注射，每周一次，同时口服安慰剂或RV片剂，每日两次。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组以及他们对治疗药物的反应。 所有患者将在停用研究药物后接受24周的密切随访，并在长期随访期间接受2次年度访视。