GMX01

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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).