Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD

Exclusion Criteria

• •Subject has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2.
• •Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
• •* Persistent alanine aminotransferase (ALT) and aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory
• •* Persistent severe neutropenia (defined as an absolute neutrophil count \[ANC\] \<= 500/mm3).
• •Subject has creatinine clearance (CLcr) value that is \<60% of normal for age and gender either measured, or calculated according to a gender-specific formula provided in the study protocol.
• •Subject has been diagnosed with or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
• •Subject is receiving anti-coagulation therapy or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening or a history of thrombophilia.
• •Subject has abnormal protein loss (protein losing enteropathy, nephrotic syndrome).
• •Subject has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site.
• •Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or Immune Serum Globulin (ISG) infusions.
• •Subject has immunoglobulin A (IgA) deficiency (IgA less than 0.07g/L) and known anti IgA antibodies.
• •Subject has a known allergy to hyaluronidase.
• •Subject is on preventative (prophylactic) systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and cannot stop these antibiotics at the time of screening.
• •Subject has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening.
• •Subject has a bleeding disorder or a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of SC therapy.
• •Subject has total protein \> 9 g/dL or myeloma, or macroglobulinemia (IgM) or paraproteinemia.
• •Women of childbearing potential meeting any one of the following criteria:
• •* Subject presents with a positive pregnancy test
• •* Subject is breast feeding
• •* Subject intends to begin nursing during the course of the study
• •* Subject does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom \[for male partner\] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study.
• •Subject has participated in another clinical study and has been exposed to an investigational product (IP) or device within 30 days prior to study enrollment (exception: treatment with immunoglobulin pre-study).
• •Subject is scheduled to participate in another (non-Baxter) clinical study involving an IP or device during the course of the study.
• •Subject has severe dermatitis that would preclude adequate sites for safe product administration.