PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

这个子项目是许多利用 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，PEG-2a联合利巴韦林（RV）和PEG-2a单独治疗儿童慢性丙型肝炎病毒（CHC）的安全性和有效性。 PEG-2a联合RV或PEG-2a单独治疗CHC儿童是否可导致更高的持续病毒学应答率？ PEG-2a（伴或不伴RV）治疗对丙型肝炎儿童的体重指数、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。 入组患者将接受PEG-2a皮下注射，每周一次，根据患者体重每日一次或两次口服安慰剂或RV片剂。 在开始研究药物治疗后，患者将在第2、4、6和8周返回接受评价，之后每4周一次，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。 根据研究访视，患者将接受以下程序： 生命体征和体格检查 抽血 妊娠试验（血清或尿液） 尿分析 低压屏 生长/身体成分（通过DXA扫描（包括骨密度扫描）进行身体成分分析，生物电阻抗分析（BIA），详细的人体测量学分析，饮食和身体活动史。 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 there after, 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 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 & 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 Ophthalmology exam