Study of PlasmaCap IG in Adults and Children With PIDD

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.