Gammagard Liquid and rHuPH20 in PID

Inclusion Criteria:

• Subject is 2 years or older at the time of screening
• Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
• Subject has been diagnosed with a PID disorder requiring antibody replacement as defined by WHO criteria
• Subject has completed or is about to complete Baxter Clinical Study Protocol No. 160601 or has been receiving a regular IGIV-treatment at mean intervals of 21 ± 3 days or 28 ± 3 days, or SC at mean intervals of 5 to 16 days, over a period of at least 3 months prior to enrollment at a minimum dose of 300 mg/kg BW/4 weeks
• Subject has a serum trough level of IgG > 4.5 g/L at the last documented determination
• If female of childbearing potential, subject presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study
• Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

• Subject is positive at enrollment or 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
• Subject has levels of alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory
• Subject has persistent severe neutropenia (defined as an absolute neutrophil count [ANC] <= 500/mm3)
• Subject has creatinine clearance values, calculated according to the formula below, which are < 60% of normal for age and gender for males: CLcr = [(140 - Age(years)) * (body weight (kg))] / [72 * (Serum Creatinine (mg/dL))] for females: CLcr = [(140 - Age(years)) * (body weight(kg)) * 0.85] / [72 * (Serum Creatinine (mg/dL))]
• Subject has malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Subject has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months
• Subject has abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
• Subject has anemia that would preclude phlebotomy for laboratory studies
• Subject has received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment
• Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin, and/or ISG infusions
• Subject has immunoglobulin A (IgA) deficiency and known anti IgA antibodies
• Subject is on preventative (prophylactic) antibiotics and cannot stop antibiotics at the time of enrollment
• Subject has active infection who started on antibiotic therapy for the treatment of infection within 7 days prior to screening
• Subject has a bleeding disorder or are on anti-coagulation therapy
• Subject has total protein > 9 g/dL and subjects with myeloma, macroglobulinemia (IgM) and paraproteinemia
• Subject has a known allergy to hyaluronidase
• If female, subject is pregnant or lactating at the time of study enrollment
• Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study; exception: Baxter Study No. 160601