IVGIV C W/ IGIV SOLVENT FOR IMMUNE DEFICIENCY

IVGIV C W/ IGIV 溶剂，用于治疗免疫缺陷

• 批准号: 6263557
• 负责人: HANS D OCHS
• 金额: $ 0.39万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263557
• 关键词: clinical research; drug adverse effect; drug screening /evaluation; human subject; humoral immunity; immunodeficiency; immunoglobulin G; immunoglobulins; immunotherapy; intravenous administration; pharmacokinetics

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.

原发性免疫缺陷疾病的患者已使用静脉内（IVIG）的免疫胶质素已有15年以上的历史，并显着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比先前许可的产品IGIV-S/D更纯净，它更加紧密地反映了在血浆中发现的IgG亚类分布，并用辣椒酸酯处理，而不是溶剂剂，而不是溶剂剂量的毒素，可抗毒性病毒。临床前分析和体内动物模型已经证明了IGIV-C与IGIV-S/D的物理，化学和功能特性相似。这将是第一项将IGIV-C与IGIV-C/D进行比较的临床试验，与IGIV-C/D进行了初级体液免疫缺乏症患者。