Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)

Exclusion Criteria

• •Received any blood product \[other than immune globulin intravenous (IGIV)\] within the last 3 months prior to screening or received any investigational agent \[other than immune globulin intravenous (IGIV)\] within the last four weeks prior to receiving Nabi-IGIV \[immune globulin intravenous (Human) 10%\].
• •Known history of medically significant adverse reactions to other immunoglobulin G (IgG) or blood products.
• •Known selective immunoglobulin A (IgA) deficiency, history of allergic reaction to products containing immunoglobulin A (IgA) or has a history of antibodies to immunoglobulin A (IgA).
• •Known significant proteinuria and/or has a history of acute renal failure/or severe renal impairment \[blood urea nitrogen (BUN) or creatinine more than 1.5 times the upper limit of normal\].
• •Known history or current diagnosis of deep venous thrombosis.
• •Known medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), or chronic or recurrent neutropenia (absolute neutrophil count less than 500 mm3).
• •Current daily use of corticosteroids (\> 10 mg of prednisone equivalent /day for \> 30 days), immunosuppressants or immunomodulators. (Intermittent corticosteroid use during the study is allowable, if medically necessary.)
• •Known non-controllable arterial hypertension (systolic blood pressure (BP) \> 160 mmHg and /or diastolic BP \>100 mmHg.)
• •Known anemia at screening (hemoglobin \<10 g/dL).
• •Subject is pregnant or lactating.
• •Known history of illicit drug use within 3 months prior to the administration of the investigational product and for the study duration.
• •Have any condition judged by the study physician to preclude participation in the study, including any psychological disorder, which might hinder compliance.
• •Known active viral or bacterial infection or symptoms/signs consistent with such an infection within the two weeks prior to the initial dose of investigational product infusion. Subjects may be on antibiotics as long as signs/symptoms of infection have been absent for two weeks prior to the initial infusion of investigational product (IP).
• •Expectation of non-compliance with the protocol procedures and visit schedule.