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OPEN-LABEL, LONG-TERM EXTENSION STUDY OF THE SAFETY AND EFFICACY OF PROLEASE HGH

OPEN-LABEL, LONG-TERM EXTENSION STUDY OF THE SAFETY AND EFFICACY OF PROLEASE HGH
PROLEASE HGH 安全性和功效的开放标签、长期延伸研究
批准号：
6118450
负责人：
MITCHELL GEFFNER
金额：
$0.19万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6118450
关键词：
child (0-11) clinical research clinical trial phase I drug administration rate /duration drug screening /evaluation hormone therapy human subject human therapy evaluation injection /infusion pediatric pharmacology peptide hormone metabolism pharmacokinetics postnatal growth disorder recombinant proteins somatotropin

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中文摘要
翻译
重组 hGH (rhGH) 的缓释制剂将允许简化给药方案，并有机会研究连续的 rhGH 的内分泌和代谢效应。 ProLease hGH 是 rhGH（生长激素，Genentech, Inc.）的一种制剂，旨在提供长达 28 天的 hGH 持续释放。 由于rhGH 主要用于患有生长障碍的儿童，因此人们对一种可减少每日注射需求的新hGH 产品特别感兴趣。
英文摘要
A sustained-release formulation of recombinant hGH (rhGH) would allow a simpli-fied administration regimen and the opportunity to investigate the endocrine and metabolic effects fo continuous of rhGH. ProLease hGH is a formulation of rhGH (somatropin, Genentech, Inc.) intended to provide continuous release of hGH for up to 28 days. Since rhGH is primarily administered to children w/growth disor-ders, there is particular interest in a new hGH product that reduces the need for daily injections.
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