RPR 109413 VS GAMIMMUNE N IN PRIMARY OR SECONDARY IMMUNE DEFICIENCY

低丙种球蛋白血症患者需要以下替代治疗： 静脉注射丙种球蛋白 目前，丙种球蛋白的唯一来源 供患者使用的是来自人血浆的供体。 最近，危险 通过使用人类血液制品传播病毒感染 在报告患者感染丙型肝炎后， 用被污染的免疫球蛋白治疗 这个项目的总体目标是 一项多中心研究旨在测试丙种球蛋白产品（RPR）的安全性 109413）由Armour Pharmaceutical Company的新方法制备， Rhone-Poulenc Rounge的子公司。 RPR 109413是一种高度纯化的， 液体静脉注射免疫球蛋白（IVIG）产品。 其主要区别 从目前市售的IVIG产品是，它包括q湿热 处理（巴氏杀菌）作为对病毒的额外保障。 本研究是双盲随机II期研究的一部分， 安全性、耐受性、有效性和生物半衰期的比较 RPR 109413和Gamimune N（10%溶液）静脉给药 剂量范围为200 mg/kg至600 mg/kg至约81 具有以下特征的原发性或继发性免疫缺陷的患者 抗体合成缺陷。 我们已经招募了11名患者， 中心

Patients with hypogammaglobulinemia require replacement therapy with intravenous gammaglobulin. At present, the only source of gammaglobulin for patients use is from donors of human plasma. Recently, the dangers of transmitting viral infections through the use of human blood products have ben re-emphasized after reports of hepatitis C infection in patients treated with contaminated immune globulin. The overall goal of this multicenter study is to test the safety of a gammaglobulin product (RPR 109413) prepared by a new method by the Armour Pharmaceutical Company, a subsidiary of Rhone-Poulenc Rorer. RPR 109413 is a highly purified, liquid intravenous immunoglobulin (IVIG) product. Its primary difference from currently marketed IVIG products is that it includes q wet heat treatment (pasteurization) as an additional safeguard against viruses. 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 Gamimmune N (10% solution) administered intravenously at a dose ranging from 200 mg/kg to 600 mg/kg to approximately 81 patients with primary or secondary immune deficiency characterized by defective antibody synthesis. We have enrolled 11 patients at this center.