Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

Inclusion Criteria:

• Confirmed diagnosis of primary immune deficiency and medical records available forretrospective review for at least 3 months prior to entry into the trial

• Signed an informed consent written informed consent prior to initiation of any studyrelated procedures

• Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into thetrial. Patients who are currently receiving less than 400 mg/kg are eligible for thistrial and will be at the time of study enrollment be treated at 400 mg/kg

Exclusion Criteria:

• History or suspicion of significant allergic reaction to intravenous immune globulin,and/or blood products

• Documented history of selective IgA deficiency (serum level <5.0 mg/dL) and knownantibodies to IgA

• Isolated IgG subclass deficiency with a normal total serum IgG level

• Other conditions which may interfere with the trial, include the patients demeanor ormental ability to follow instruction.

• Pretreatment with anti-pyretics or anti-histamines

• Congestive heart failure (New York Heart Association stage greater than Class II)

• Renal insufficiency (creatinine >2.5 mg/dL)

• Conditions whose symptoms and effects could alter protein catabolism and/or IgGutilization (e.g. protein-losing enteropathies, nephrotic syndrome)

• Pretreatment routinely required to control/ameliorate IGIV infusion-related adverseevents (AEs)

• Any patient who requires IGIV dosing more frequently than every 3 weeks to maintainadequate trough levels

• Women of child bearing potential who do not practice adequate contraception (i.e.chemical or mechanical methods) and pregnant or lactating females