Study of PlasmaCap IG in Adults and Children With PIDD

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or planning a pregnancy during the course of the study (women who become pregnant during the study will be withdrawn from the study).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.