CLINICAL TRIAL: L2762G EFF OF NUTROPIN AQ FOR TRMT OF GROWTH RESTRICTION IN CHIL

临床试验：NUTROPIN AQ 的 L2762G 对儿童生长受限 TRMT 的功效

• 批准号: 7717102
• 负责人: Michael Shane Stalvey
• 金额: $ 0.22万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717102
• 关键词: Blood Glucose; Chemistry; Chronic Disease; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; DEXA; Dietary intake; Funding; Grant; Growth; Height; Immunologics; Institution; Intake; Label; Measurement; Metabolic; Nutritional; Phase; Population; Pulmonary function tests; Randomized; Reporting; Research; Research Personnel; Resources; Safety; Scanning; Serum; Source; Symptoms; United States National Institutes of Health; Vital capacity; Weight; children with cystic fibrosis; cystic fibrosis patients; design; improved; nutropin; pulmonary function; r-hGH-M; response

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. Nutropin AQ is a recombinant human growth hormone rhGH. The use of rhGH for the treatment of growth restriction has been demonstrated in other chronic diseases. Treatment with rhGH can result in significant improvement in growth and lean body mass. There are some small studies which have shown that rHGH may improve the forced vital capacity in pulmonary function. Children with Cystic Fibrosis characteristically have reduced linear growth, which is predictive of declines in pulmonary function. The restricted growth in Cystic Fibrosis is multi-factorial, but probably due to a combination of poor dietary intake and increased metabolic demands. Adequate nutritional intake has not improved growth in Cystic Fibrosis patients when compared to a normal population. The proposed study is a phase II, multicenter, randomized, controlled, open-label study of the safety and efficacy of using rhGH in growth restricted children with Cystic Fibrosis. The study is designed to determine the effect of Nutropin AQ on growth restriction, lean body mass and pulmonary function in children with Cystic Fibrosis. Safety parameters will be a measurement of blood glucose levels, pulmonary function testing, and any changes in serum chemistries, immunologic response to the rhGH, as well as reported or observed symptoms of subjects. Efficacy will be a measurement of height and weight, pulmonary function testing, and dual energy x-ray absorptiometry DEXA scans.

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。 Nutropin AQ是一种重组人生长激素rhGH。 使用rhGH治疗生长受限已在其他慢性疾病中得到证实。 用rhGH治疗可以显著改善生长和瘦体重。 有一些小型研究表明，rHGH可能会改善肺功能中的用力肺活量。患有囊性纤维化的儿童的特征是线性生长减少，这预示着肺功能下降。 囊性纤维化的生长受限是多因素的，但可能是由于饮食摄入不足和代谢需求增加的组合。 与正常人群相比，充足的营养摄入并没有改善囊性纤维化患者的生长。 拟定研究是一项II期、多中心、随机、对照、开放标签研究，旨在评估生长受限囊性纤维化儿童使用rhGH的安全性和有效性。 本研究旨在确定Nutropin AQ对囊性纤维化儿童生长受限、瘦体重和肺功能的影响。 安全性参数将是血糖水平测量、肺功能检查和血清化学的任何变化、对rhGH的免疫应答以及受试者报告或观察到的症状。 疗效将是身高和体重测量、肺功能测试和双能X线吸收法DEXA扫描。