Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency

Exclusion Criteria

• •Known serious adverse reaction to immunoglobulin or any severe anaphylactic reaction to blood or any blood-derived product
• •History of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study
• •Isolated IgG subclass deficiency, isolated specific antibody deficiency disorder, or transient hypogammaglobulinemia of infancy
• •Nephrotic syndrome, and/or a history of acute renal failure and/or severe renal impairment, and/or on dialysis
• •History (year prior to Screening or 2 episodes in lifetime ) of or current diagnosis of deep venous thrombosis or thromboembolism (eg, deep vein thrombosis, myocardial infarction, cerebrovascular accident or transient ischemic attack)
• •Acquired medical condition known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/μL \[1.0 x 10\^9/L\]), or human immunodeficiency virus infection/acquired immune deficiency syndrome
• •Known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection
• •Non-controlled arterial hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg in adult subjects)
• •Receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents, (b) immunomodulators, (c) long-term systemic corticosteroids defined as daily dose \>1 mg of prednisone equivalent/kg/day for\>30 days Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a subject. Inhaled or topical corticosteroids are allowed.