A PARALLEL GROUP STUDY OF SAFETY AND EFFICACY OF THE LB03002 A NEW SUSTAINED

LB03002 的安全性和有效性的平行小组研究

• 批准号: 7603566
• 负责人: GAIL E RICHARDS
• 金额: $ 0.05万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603566
• 关键词: Child; Coin; Computer Retrieval of Information on Scientific Projects Database; Daily; Enrollment; Europe; Funding; Genotropin; Grant; Injection of therapeutic agent; Institution; Participant; Preparation; Puberty; Randomized; Recombinant Growth Hormone; Research; Research Personnel; Resources; Safety; Screening procedure; Somatotropin; Source; Standards of Weights and Measures; Testing; United States; United States National Institutes of Health; Visit; aged; day; girls; new growth

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. Children who are short and do not produce enough growth hormone have been treated for the past 30 years with a daily injection of recombinant growth hormone. This study is a test of a new sustained release formation of recombinant growth hormone (LB03002). In this research, children who have not entered puberty yet, who are short and not making enough growth hormone will be divided in to two groups randomly (like tossing a coin). One group will be treated with a weekly injection of the the new growth hormone preparation. The second group will be treated with daily injections of a standard growth hormone preparation. The primary objective of the study is to demonstrate that LB03002 administered as a weekly injection, is clinically comparable to daily injections of the standard growth hormone, Genotropin. 144 children aged 3-11 (girls 3-10) in 40 centers in Europe and the United States will be enrolled with 72 randomized to receive LB03002 and 72 to receive Genotropin. Participants will be enrolled for 1 year (+ up to 28 days for screening), which will include 6 visits (plus 1-2 additional visits for screening).

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。 在过去的30年里，矮小且不能产生足够生长激素的儿童每天注射重组生长激素。 本研究是重组生长激素（LB 03002）新型缓释制剂的试验。 在这项研究中，还没有进入青春期的孩子，谁是短，没有足够的生长激素将被随机分为两组（像抛硬币）。 一组每周注射一次新的生长激素制剂。 第二组将每天注射标准生长激素制剂。 本研究的主要目的是证明每周注射一次LB 03002在临床上与每日注射标准生长激素Genotropin相当。 将在欧洲和美国的40个中心招募144名3-11岁儿童（3-10岁女孩），其中72名随机接受LB 03002，72名接受Genotropin。 受试者将入组1年（筛选期最多28天），包括6次访视（加上1-2次额外的筛选访视）。