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RPR 109413 VS GAMIMMUNE N IN PRIMARY OR SECONDARY IMMUNE DEFICIENCY

RPR 109413 VS GAMIMMUNE N IN PRIMARY OR SECONDARY IMMUNE DEFICIENCY
RPR 109413 与 GAMIMMUNE N 在原发性或继发性免疫缺陷中的比较
批准号：
6244014
负责人：
HARRY W SCHROEDER
金额：
$2.46万
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：
1997
资助国家：
美国
项目状态：
已结题
起止时间：
1997-02-10 至 1997-11-30
来源：
https://reporter.nih.gov/project-details/6244014
关键词：
clinical research drug adverse effect drug screening /evaluation gamma globulin human subject human therapy evaluation hypogammaglobulinemia immunodeficiency intravenous administration pharmacokinetics

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中文摘要
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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 present study is part of a double-blind randomized phase II comparison of the safety, tolerance, efficacy, and biological 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 approximately 81 patients from up to ten centers with primary or secondary immune deficiency characerized by defective antibody synthesis.
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GENETIC ANALYSIS OF RHEUMATOID ARTHRITIS SIBLING PAIRS
RPR 109413 VERSUS GAMIMMUNE N WITH PRIMARY OR SECONDARY IMMUNE DEFICIENCY
GENETIC ANALYSIS OF RHEUMATOID ARTHRITIS SIBLING PAIRS
TRANSGENIC STUDIES OF TCR REPERTOIRE DIVESIFICATION