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
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-01-26 至 1998-11-30
• 项目状态: 已结题
• 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

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.

RPR 109413是一种高度纯化的液体静脉注射免疫球蛋白（IVIG） 产品 它与目前上市的IVIG产品的主要区别是 它包括湿热处理（巴氏灭菌）作为额外的 防止病毒颗粒。 这项研究是双盲的， 安全性、耐受性、有效性和 RPR 109413和Gamimune N的生物半衰期（10%溶液） 以200 mg/kg至600 mg/kg的剂量静脉内给药 80多名原发性或继发性免疫缺陷患者 以抗体合成缺陷为特征。 进行治疗 作为门诊病人