RPR 109413 VERSUS GAMIMMUNE N WITH PRIMARY OR SECONDARY IMMUNE DEFICIENCY

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

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.