Immunologic Deficiency Syndrome Clinical Trial
Official title:
An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in Subjects With Primary Immunodeficiency
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
This is an open-label, single-arm, historically controlled, prospective, multicenter phase
III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin
Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
Subject will be infused every 21 to 28 days according to their previous IVIG treatment
schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject
treated every 21 days will receive 17 study IVIG infusions.
Duration of treatment:The total duration of treatment is 12 months.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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