PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，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，儿童将按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）随机分为两组。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peg -2a治疗儿童慢性丙型肝炎病毒（CHC）的安全性和有效性是什么？PEG-2a联合RV还是单独使用PEG-2a在CHC儿童中产生更高的持续病毒学应答率？PEG-2a（合并或不合并RV）治疗对丙型肝炎儿童的体重指数、身体成分和线性生长有什么影响？接受PEG-2a治疗（伴或不伴RV）的儿童的短期和长期结果（包括健康相关的生活质量、认知和发育功能、社会心理功能和行为）是如何表征的？入选的患者将接受每周一次的皮下PEG-2a注射，同时根据患者的体重口服安慰剂或RV片剂，每天一次或两次。研究药物开始后，患者将在第2、4、6和8周进行评估，之后每4周进行一次评估，同时接受研究药物治疗。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。所有患者在停用研究药物后随访24周，长期随访期间每年随访2次。根据研究访问，患者将接受以下程序：生命体征和；体检，抽血，妊娠试验，（血清或尿液）尿液分析，抑郁筛查，生长/身体成分(DXA扫描身体成分分析，（包括骨密度扫描），生物电阻抗分析（BIA），详细的人体测量学分析，饮食和体育活动史，生活质量问卷，眼科检查。

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? Enrolled patients will receive a subcutaneous PEG-2a injection once a week given with placebo or RV tablet/s given orally once or twice daily, depending on the patient's weight. Following the initiation of study drug, patients will return for evaluation at weeks 2, 4, 6 and 8, and then every 4 weeks thereafter, while receiving study drug therapy. Patients will be treated for 24-48 weeks depending on which treatment arm they are randomized to, and their response to the 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. Depending on the study visit, the patients will undergo the following procedures: Vital signs amp; physical exam, Blood draw, Pregnancy test, (serum or urine)Urinalysis, Depression screen, Growth/body composition (body composition analysis by DXA scan, (including bone density scans), bioelectrical impedance analysis (BIA), detailed anthropometrics analysis, diet and physical activity history, Quality of Life questionnaire, and Ophthalmology exam.