IVGIV C W/ IGIV SOLVENT FOR IMMUNE DEFICIENCY

静脉注射免疫球蛋白（IVIG）用于原发性免疫缺陷疾病患者已超过15年，并显著改善了受影响患者的健康状况。为了提高该产品的质量、有效性和安全性，IGIV-C比先前获得许可的产品IGIV-S/D更纯净，更能反映血浆中IgG亚类的分布，并且用巯基酸而不是溶剂洗涤剂处理以灭活肝炎等病毒。临床前分析和体内动物模型已经证明IGIV-C与IGIV-S/D具有相似的物理、化学和功能特性。这将是第一个比较IGIV-C和IGIV-S/D在原发性体液免疫缺陷患者中的药代动力学和安全性的临床试验。

Immunoglubulin for intravenous (IVIG) has been used for more than 15 years in patients with primary immunodeficiency diseases and has dramatically improved the health status of affected patients. In an effort to improve the quality, effectiveness, and safety of this product, IGIV-C, is purer than the previously licensed product, IGIV-S/D, more closely reflects the IgG subclass distribution found in plasma, and is treated with caprylate rather than solvent-detergent to inactivate viruses such as hepatitis. Preclinical analytical and in vivo animal models have demonstrated the similar physical, chemical and functional properties of IGIV-C to IGIV-S/D. This will be the first clinical trial to compare the pharmacokinetics and safety profile of IGIV-C with IGIV-S/D in patients with primary humoral immune deficiency.