PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

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。 本研究是一项III期、多中心、随机、盲法、安慰剂对照试验，旨在比较聚乙二醇化干扰素a2 a（PEG-2a）加安慰剂与PEG-2a加利巴韦林（RV）的安全性和疗效。这是一项由11所大学中心和NIDDK合作的研究。共有112名（丹佛5 - 15名）5-18岁的儿童将入组本研究。入组的患者将接受PEG-2a皮下注射，每周一次，与安慰剂或RV片剂一起口服，每日一次或两次，持续48周（可能长达76周），具体取决于患者的体重。患者将通过计算机生成的随机化方案以1：1（50：50）的比例随机分配至PEG-2a+安慰剂组与PEG-2a + RV组。 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，此后每4周一次，同时接受研究药物治疗。 患者将在停止研究药物治疗后接受约2年以上的随访。 主要疗效结局是治疗结束后24周血清HCV-RNA检测不到。主要安全性结局为生命体征、实验室检查和临床不良事件。次要结果将包括生长（身高，体重，人体测量学），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.