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: 6112810
• 负责人: HARRY W SCHROEDER
• 金额: $ 3.06万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6112810
• 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是一种高纯度液体静脉注射免疫球蛋白（IVIG）。