Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

Exclusion Criteria

• •Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
• •Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory. An AST \> 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
• •Subjects with neutropenia (defined as an ANC \>= 1,000/mm3)
• •Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
• •Subjects with malignancy or a history of malignancy
• •Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
• •Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
• •Subjects with selective complete IgA deficiency
• •Subjects with moderate levels of anti-IgA antibodies (\>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
• •Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
• •Subjects who receive prophylactic antibiotics as part of their care regimen
• •Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry