RPR 109413 VS GAMIMMUNE N IN PRIMARY OR SECONDARY IMMUNE DEFICIENCY

Rpr 109413是一种高纯度的液体静脉注射免疫球蛋白。 (IVIG)产品。它与目前市场上的静脉注射免疫球蛋白的主要区别 产品的特点是它包括湿热处理(巴氏杀菌) 针对病毒颗粒的额外保护措施。目前的研究是 部分安全性的双盲随机第二阶段比较， Rpr 109413和Gamimune的耐受性、有效性和生物半衰期 N(10%溶液)静脉注射，剂量从200 毫克/公斤至600毫克/公斤，向来自最多10个中心的约81名患者提供 以缺陷为特征的原发或继发性免疫缺陷 抗体合成。

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.