课题基金 / 基金详情

RPR 109413 VERSUS GAMIMMUNE N WITH PRIMARY OR SECONDARY IMMUNE DEFICIENCY

RPR 109413 VERSUS GAMIMMUNE N WITH PRIMARY OR SECONDARY IMMUNE DEFICIENCY
RPR 109413 与患有原发性或继发性免疫缺陷的 GAMIMMUNE N 相比
批准号：
6274044
负责人：
HARRY W SCHROEDER
金额：
$2.59万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
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：
1998-01-26 至 1998-11-30
来源：
https://reporter.nih.gov/project-details/6274044
关键词：
clinical research drug adverse effect drug screening /evaluation gamma globulin human subject human therapy evaluation hypogammaglobulinemia immunodeficiency intravenous administration pharmacokinetics

项目摘要

项目成果

HARRY W SCHROEDER的其他基金

相关文献

中文摘要
翻译
RPR 109413是一种高纯度液体静脉注射免疫球蛋白（IVIG）。
英文摘要
RPR 109413 is a highly purified, liquid intravenous immunoglobulin (IVIG) product. Its primary difference from currently marketed IVIG products is that it includes a wet heat treatment (pasteurization) as an additional safeguard against virus particles. The study was a double-blind randomized Phase II comparison of the safty, tolerance, efficacy, and bioligical half-life of RPR 109413 and Gamimune N( (10% solutions) administered intravenously at a dose ranging from 200 mg/kg to 600 mg/kg to more than 80 patients with primary or secondary immune deficiency characterized by defective antibody synthesis. The patients were treated as outpatient.
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