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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它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 III 期多中心、随机安慰剂对照试验。这些儿童将以 1:1 的比例随机分配到 2 组中的一组（PEG-2a （聚乙二醇化干扰素）+ 利巴韦恩与 PEG 2a + 安慰剂）根据计算机生成的随机代码。 本研究的目的是回答聚乙二醇干扰素α-2a（PEG-2a）联合利巴韦恩（RV）和单独使用PEG-2a治疗慢性丙型肝炎病毒（HCV）的安全性和有效性。孩子们？ PEG-2a 与 RV 联合使用或单独使用 PEG-2a 是否会导致 HCV 儿童获得更高的持续病毒学应答率？ PEG-2a（联合或不联合 RV）治疗对 HCV 儿童的体重指数、身体成分和线性生长有何影响？ 接受 PEG-2a（伴或不伴 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、认知和发育功能以及心理社会功能和行为如何表征？ 入组患者将每周接受一次皮下 PEG-2a 注射，同时每天口服两次安慰剂或 RV 片剂。患者将接受 24-48 周的治疗，具体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。 所有患者在停止研究药物后将接受为期24周的密切随访，并在长期随访期间每年进行2次随访。