Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously

Inclusion Criteria:

- Written informed consent from either the subject or the subject's legally acceptable
representative

- Diagnosis of a PID disorder as defined by World Health Organization criteria1 for
which the subject had been receiving a regimen of weekly or biweekly
(every-other-week) subcutaneous IgG infusions or IGIV infusions every 21 to 28 days
over a period of at least 8 weeks pre-study at an equivalent of a 4-week dose of 300
to 800 mg/kg bodyweight

- Adults/adolescents aged 16 years and older)

- For female subjects of child-bearing age: negative urine pregnancy test result at
study entry and agreement to employ adequate birth control measures for the duration
of the study

Exclusion Criteria:

- Subjects positive at enrollment for one or more of the following: HBsAg, PCR for HCV,
PCR for HIV Type 1

- Subjects with levels of alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) > 2.5 times the upper limit of normal for the testing laboratory

- Subjects with neutropenia (defined as an absolute neutrophil count [ANC] <= 500/mm3).

- Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal
for age and gender

- Subjects with current history of malignancy

- Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial
infarction, cerebrovascular accident)

- Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome,
severe lung disease)

- Subjects with anemia that in the opinion of the investigator precluded phlebotomy for
laboratory studies

- Subjects who had been exposed to any blood or blood product other than an intravenous
immunoglobulin (IGIV), SC immunoglobulin (SCIG), immune serum globulin (ISG)
preparations, or albumin 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,
SCIG and/or ISG infusions

- Subjects with IgA deficiency and known anti IgA antibodies

- Subjects who had received antibiotic therapy for the treatment of infection within 7
days prior to enrollment

- Subjects who had participated in another clinical study involving an investigational
product or device within 28 days prior to study entry

- Subjects with inability or unwillingness to meet all the requirements of this study

- If female, pregnancy or lactation at time of study entry