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。该研究是一项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a2a （PEG-2a）加安慰剂与PEG-2a加利巴韦林（RV）的安全性和有效性。这是11所大学中心和NIDDK的一项合作研究。共有112名5-18岁的儿童（丹佛5- 15岁）将参加这项研究。入选的患者将接受每周一次皮下PEG-2a治疗，同时服用安慰剂或RV片剂，每日口服1次或2次，疗程取决于患者的体重，持续48周（可能长达76周）。通过计算机生成的随机化方案，患者将按1:1（50:50）的比例随机分为PEG-2a +安慰剂组和PEG-2a + RV组。在研究药物开始后，患者将在第2、4、6和8周返回进行评估，之后每4周进行一次评估，同时接受研究药物治疗。患者将在停止研究药物治疗后随访约2年以上。主要疗效指标是治疗结束后24周血清HCV-RNA检测不到。主要的安全性结果是生命体征、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）、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.