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: 7607765
• 负责人: WILLIAM F BALISTRERI
• 金额: $ 3.73万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607765
• 关键词: Age; Behavior; Body Composition; Body mass index; Child; Chronic; Cognitive; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Development; Enrollment; Funding; Goals; Grant; Growth; Hepatitis C; Hepatitis C virus; Institution; Interferons; Outcome; Phase; Randomized; Range; Rate; Research; Research Personnel; Resources; Ribavirin; Safety; Source; United States; United States National Institutes of Health; Visit; Week; follow-up; health related quality of life; peginterferon alfa-2a; psychologic; response; treatment duration

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. The goals of this study include: I. To assess the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children. II. To determine whether PEG-2a in combination with RV or PEG-2a alone will result in a higher sustained virologic response rate in children with CHC. III. To examine the effects of PEG-2a (with or without concomitant RV) treatment on body mass index, body composition, and linear growth in children infected with hepatitis C. IV. To characterize short- and long-term outcomes, including health-related Quality of Life (QOL), cognitive and developmental and psychological functioning, and behavior in children treated with PEG-2a (with or without concomitant RV). This 5 year study will enroll 112 children between the ages of 5-18 who are infected with hepatitis C. The children will be enrolled from 11 participating centers across the United States. Children will be randomized into groups that receive PEG 2a alone or a combination of PEG 2a and ribavirin. Treatment duration can range from 48 weeks up to 100 weeks depending on how the child responds to treatment. Children who do not respond to PEG 2a alone will be switched to the combination therapy group at week 24. Following completion of the treatment phase, there is a 20 week untreated follow-up period as well as annual visits for the next 2 years thereafter.

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。 本研究的目标包括： I. 评价聚乙二醇干扰素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（CHC）感染的安全性和有效性。 二. 确定PEG-2a联合RV或PEG-2a单药治疗CHC儿童是否会导致更高的持续病毒学应答率。 三. 检查PEG-2a（伴或不伴RV）治疗对丙型肝炎感染儿童的体重指数、身体组成和线性生长的影响。 四. 描述接受PEG-2a治疗（伴或不伴RV）的儿童的短期和长期结局，包括健康相关生活质量（QOL）、认知、发育和心理功能以及行为。 这项为期5年的研究将招募112名年龄在5-18岁之间感染丙型肝炎的儿童。 这些儿童将从美国11个参与中心招募。 儿童将被随机分为单独接受PEG 2a或PEG 2a和利巴韦林联合治疗的组。治疗持续时间可以从48周到100周不等，这取决于孩子对治疗的反应。对PEG 2a单药治疗无反应的儿童将在第24周时转为联合治疗组。 治疗阶段完成后，有一个20周的未治疗随访期，以及此后2年的年度访视。