GMX01

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目前IVIG供应严重短缺，导致一些患者难以获得IVIG，同时价格也大幅上涨。价格上涨和采购困难对原发免疫缺陷疾病患者的生活造成了重大影响，因为如果这些患者无法获得或负担得起静脉注射免疫球蛋白，他们很容易受到感染。因此，迫切需要新的IVIG供应商。这项研究是生物制品实验室生产的人免疫球蛋白静脉注射新制剂Gammaplex的III期多中心开放标签研究。这项研究的主要目的是确定GAMMAPLEX在食品和药物管理局(FDA)的最低要求(每个受试者每年不超过1例严重、急性、细菌感染)方面是否有效。

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).