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
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-10 至 1997-11-30
• 项目状态: 已结题
• 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

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.

RPR 109413是一种高度纯化的液体静脉注射免疫球蛋白 （IVIG）产品。 其与目前市售IVIG的主要区别 产品的特点是它包括湿热处理（巴氏杀菌）， 对病毒颗粒的额外保护。 本研究报告是 安全性双盲随机II期比较的一部分， RPR 109413和Gamimune的耐受性、疗效和生物半衰期 N（10%溶液）静脉内给药，剂量范围为200 10家临床试验机构的约81例患者接受了mg/kg至600 mg/kg的剂量 以缺陷型为特征的原发性或继发性免疫缺陷 抗体合成