GMX01

GMX01

• 批准号: 7603494
• 负责人: ANDREW M. SCHARENBERG
• 金额: $ 0.78万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603494
• 关键词: Acute; Bacterial Infections; Computer Retrieval of Information on Scientific Projects Database; Disease; Funding; Grant; Human; Immunologic Deficiency Syndromes; Infection; Institution; Intravenous Immunoglobulins; Label; Laboratories; Life; Patients; Phase; Preparation; Price; Research; Research Personnel; Resources; Source; United States Food and Drug Administration; United States National Institutes of Health

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There is presently a major shortage of IVIG available, resulting in difficulty in procurement of IVIG for some patients as well as significant price increases. The price increases and difficulty in procurement cause major impacts on the lives of patients with primary immunodeficiency diseases, as such patients are highly susceptible to infection if they are not able to obtain or afford IVIG. Therefore, new suppliers of IVIG are urgently needed. This study is a phase III multi-center open label study of Gammaplex, a new preparation of human immunoglobulin, intravenous, manufactured by Bioproducts Laboratory. The primary objective of this study is to determine if GAMMAPLEX is efficacious with respect to the Food and Drug Administration's (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Disease (PID).

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目前，可用的IVIG严重短缺，导致一些患者难以获得IVIG以及价格大幅上涨。价格上涨和采购困难对原发性免疫缺陷病患者的生活造成重大影响，因为这些患者如果无法获得或负担不起免疫球蛋白，就极易受到感染。因此，迫切需要新的IVIG供应商。本研究是一项关于Gammaplex（一种新的静脉注射人免疫球蛋白制剂，由Bioproducts Laboratory生产）的III期多中心开放标签研究。本研究的主要目的是确定在原发性免疫缺陷病（PID）受试者中，根据美国食品药品监督管理局（FDA）的最低要求（每例受试者每年不超过1例严重、急性细菌感染），GAMMAPLEX是否有效。