PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究是一项第三阶段、多中心、随机、盲目、安慰剂对照试验，比较聚乙二醇化干扰素A2a(PEG化干扰素A2a)加安慰剂与聚乙二醇化干扰素A2a加利巴韦林(RV)的安全性和有效性。这是一项由11个大学中心和NIDDK合作进行的研究。共有112名(丹佛市5至15岁)5-18岁的儿童将参加这项研究。入选的患者将接受每周一次的皮下注射聚乙二醇2a，同时服用安慰剂或房车片/S，每天口服一到两次，持续48周(可能长达76周)，具体取决于患者的体重。通过计算机生成的随机方案，患者将按1：1(50：50)的比例随机接受聚乙二醇2a加安慰剂与聚乙二醇2a加RV。在开始研究药物后，患者将在第2、4、6和8周返回接受评估，然后在接受研究药物治疗的同时每4周进行一次评估。在停止研究药物治疗后，患者将被跟踪大约2年以上。 主要疗效结果是在治疗结束24周后检测不到血清中的丙型肝炎病毒核糖核酸。主要的安全结果是生命体征、实验室测试和临床不良事件。次要结果将包括生长(身高、体重、人体测量)、身体成分(DEXA、BIA)和生活质量评估。

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 study is a Phase III, multicenter, randomized, blinded, placebo-controlled trial to compare safety and efficacy of pegylated interferon a2a (PEG-2a) plus placebo vs. PEG-2a plus ribavirin (RV). It is a collaborative study by 11 university centers and the NIDDK. A total of 112 (and between 5 and 15 in Denver) children 5-18 years of age will be enrolled in the study. Enrolled patients will receive subcutaneous PEG-2a once a week given with placebo or RV tablet/s given orally once or twice daily, depending on the patient's weight for 48 (possibly up to 76) weeks. Patients will be randomized to PEG-2a plus placebo vs. PEG-2a plus RV in a 1:1(50:50) ratio by a computer-generated randomization scheme. 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 followed for approximately 2+ years after discontinuing study drug therapy. The primary efficacy outcome is non detectable serum HCV-RNA 24 weeks after the end of treatment. The primary safety outcomes are vital signs, laboratory tests and clinical adverse events. Secondary outcomes will include growth (height, weight, anthropometrics), body composition (DEXA, BIA) and quality-of-life assessment.