Study of PlasmaCap IG in Adults and Children With PIDD

This is an interventional treatment trial for Primary Immune Deficiency Diseases (PIDD) Read More

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.