Clinical Research Directory

Inclusion Criteria: * Subject has a confirmed clinical diagnosis of a PIDD, which requires treatment with IGIV: * Subject/guardian has provided written informed consent (and assent, as applicable). * Subject is between the ages of 2 and 70 years. * Subject has received regular IGIV therapy at 21- or 28-day (±4 days) intervals for at least three consecutive months at a dose between 300-900 mg/kg/month prior to Screening or; * Subject has received commercial SCIG at a dose of 300-900 mg/kg/month on any dosing schedule for at least 12 consecutive weeks prior to Screening. Subjects on SCIG must have received and tolerated IGIV treatment prior to SCIG treatment. * Subject has a documented trough of ≥500 mg/dL in the 6 months prior to screening. * Females of childbearing potential must be willing to use an effective form of birth control (eg, oral contraceptives) for the duration of the study, per IRB/REB guidelines. * Subject agrees to comply with the requirements of the protocol. Exclusion Criteria: * Subject has secondary immunodeficiency. * Subject has history of thrombotic events, such as deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, etc within the year prior to screening. * Subject has had an immune globulin associated arterial or venous thrombotic/thromboembolic event (TEE) within 7 days of infusion or a TEE that is not associated with an immune globulin within one year of screening. * Subject has received blood products (except for IGIV, SCIG, or albumin) within 6 months of screening. * Subject has anemia (≤8.5 g/dL). * Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3.0 times the upper limit of normal (ULN). * Subject has severe neutropenia (≤1000 neutrophils per mm3). * Subject is receiving other immunosuppressive or immunomodulatory drugs or chemotherapy. * Subject is taking or has taken within the four weeks prior to screening prednisone at ≥0.15 mg/kg/day for more than 10 days. * Subject has ever had a severe anaphylactic reaction to a blood or IgG product. * Subject has lymphoid malignancy, leukemia, or any other history of malignancy within the past five years, except squamous cell or basal cell carcinoma of the skin (not melanoma). * Subject has hypoalbuminemia, protein-losing enteropathy, or proteinuria greater than 300 mg/24 hours except for subjects with documented orthostatic proteinuria. * Subject has immunoglobulin A (IgA) deficiency with known antibodies to IgA. * Female who is pregnant, breastfeeding, or planning a pregnancy during the course of the study (women who become pregnant during the study will be withdrawn from the study). * Any condition that is likely to interfere with evaluation of IMP or satisfactory conduct of the trial in the PI's opinion. * Subjects who may not be compliant or have a history of non-compliance in the opinion of the PI.