A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency

Exclusion Criteria

• •Has not been treated with IGIV (treatment naive subject)
• •The subject has a history of any severe anaphylactic reaction to blood or any blood-derived product.
• •The subject is known to be intolerant to any component of Gammaplex, such as sorbitol (i.e. intolerance to fructose).
• •The subject has selective IgA deficiency, history of reaction to products containing IgA, or has a history of antibodies to IgA.
• •Subjects who have completed the study and subjects who have withdrawn cannot participate in the study for a second time.
• •The subject is currently receiving, or has received, any investigational agent, other than an immune serum globulin (ISG) preparation that is being evaluated in a Phase III or IIIb study, within the prior 3 months.
• •The subject has been exposed to blood or any blood product or derivative within the last 6 months, other than a commercially available IGIV or other forms of commercially available and licensed ISG. If an unlicensed ISG product that is in Phase III or IIIb has been given, the subject cannot be infused with Gammaplex until 20 days after the last dose was given.
• •The subject is pregnant or is nursing.
• •The subject, at screening, has levels greater than 2.5 times the upper limit of normal as defined at the central laboratory of any of the following: (Alanine transaminase (ALT); Aspartate transaminase (AST) Lactate dehydrogenase (LDH)).
• •The subject has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); the subject is on dialysis; the subject has a history of acute renal failure.
• •The subject is known to abuse alcohol, opiates, psychotropic agents, or other chemicals or drugs, or has done so within the past 12 months.
• •The subject has a history of DVT, or thrombotic complications of IGIV therapy.
• •The subject suffers from any acute or chronic medical condition (e.g. renal disease or predisposing conditions for renal disease, or protein losing state) that, in the opinion of the investigator, may interfere with the conduct of the study.
• •The subject has an acquired medical condition, such as, chronic or recurrent neutropenia (ANC \< 1000 x 109/L) or AIDS known to cause secondary immune deficiency, or is post or recovering from hematopoietic stem cell transplantation.
• •The subject is receiving the following medication: Systemic long-term corticosteroids (i.e. not intermittent or burst, daily, \>1 mg of prednisone equivalent/kg/day).
• •The subject is receiving Immunosuppressive or Immunomodulatory drugs.
• •The subject has non-controlled arterial hypertension.
• •The subject has anemia (hemoglobin \<10 g/dL) at screening.