L2762G EFF OF NUTROPIN AQ FOR TRMT OF GROWTH RESTRICTION IN CHILD W CF
L2762G NUTROPIN AQ 对儿童 W CF 生长受限 TRMT 的功效
基本信息
- 批准号:7374685
- 负责人:
- 金额:$ 1.06万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2005
- 资助国家:美国
- 起止时间:2005-12-01 至 2006-11-30
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
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.
该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者(PI)可能从另一个NIH来源获得主要资金,因此可以在其他CRISP条目中表示。所列机构为中心,不一定是研究者所在机构。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。疗效将是测量身高和体重、肺功能检查和双能X线吸收测定法(DEXA)扫描。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Terence R. Flotte其他文献
Swinging for the fences: persistent and efficient liver-directed gene therapy for hemophilia A
摇摆不定:针对血友病 A 的持续有效的肝脏定向基因治疗
- DOI:
- 发表时间:
2004 - 期刊:
- 影响因子:0
- 作者:
Terence R. Flotte - 通讯作者:
Terence R. Flotte
Asymptomatic Chlamydia trachomatis infections among sexually active men.
性活跃男性中的无症状沙眼衣原体感染。
- DOI:
10.1093/infdis/154.5.900 - 发表时间:
1986 - 期刊:
- 影响因子:0
- 作者:
George H. Karam;David H. Martin;Terence R. Flotte;Frank O. Bonnarens;John R. Joseph;Tomasz F. Mroczkowski;William D. Johnson - 通讯作者:
William D. Johnson
Real time laryngoscopy with olfactory challenge for diagnosis of psychogenic stridor
实时喉镜嗅觉激发诊断心因性喘鸣
- DOI:
- 发表时间:
1993 - 期刊:
- 影响因子:3.1
- 作者:
S. Tomares;Terence R. Flotte;D. Tunkel;M. Pao;G. Loughlin - 通讯作者:
G. Loughlin
Immunity to adeno-associated virus serotype 2 delivered transgenes imparted by genetic predisposition to autoimmunity
对腺相关病毒血清型 2 传递的转基因的免疫力是由自身免疫遗传倾向赋予的
- DOI:
- 发表时间:
2004 - 期刊:
- 影响因子:5.1
- 作者:
Ying Zhang;Matthew Powers;C. Wasserfall;T. Brusko;Sihong Song;Terence R. Flotte;Richard O. Snyder;Mark Potter;Marda Scott;M. Campbell;James M. Crawford;Harry S. Nick;A. Agarwal;T. Ellis;Mark A. Atkinson - 通讯作者:
Mark A. Atkinson
498. AAV Δ264CFTR Enhances Maturation of ΔF508CFTR and wt CFTR Expression
- DOI:
10.1016/j.ymthe.2006.08.568 - 发表时间:
2006-01-01 - 期刊:
- 影响因子:
- 作者:
Liudmila Cebotaru;Terence R. Flotte;William B. Guggino - 通讯作者:
William B. Guggino
Terence R. Flotte的其他文献
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{{ truncateString('Terence R. Flotte', 18)}}的其他基金
Optimized Gene Replacement for AAT deficiency and Modeling of Clinical Outcomes in small and large animal models
针对 AAT 缺陷的优化基因替换以及小型和大型动物模型中的临床结果建模
- 批准号:
10674943 - 财政年份:2021
- 资助金额:
$ 1.06万 - 项目类别:
Optimized Gene Replacement for AAT deficiency and Modeling of Clinical Outcomes in small and large animal models
针对 AAT 缺陷的优化基因替换以及小型和大型动物模型中的临床结果建模
- 批准号:
10463807 - 财政年份:2021
- 资助金额:
$ 1.06万 - 项目类别:
Optimized Gene Replacement for AAT deficiency and Modeling of Clinical Outcomes in small and large animal models
针对 AAT 缺陷的优化基因替换以及小型和大型动物模型中的临床结果建模
- 批准号:
10270092 - 财政年份:2021
- 资助金额:
$ 1.06万 - 项目类别:
New Approaches to Gene Therapy for Alpha-1 Antitrypsin Deficiency
治疗 Alpha-1 抗胰蛋白酶缺乏症的基因治疗新方法
- 批准号:
9322543 - 财政年份:2016
- 资助金额:
$ 1.06万 - 项目类别:
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