Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

Exclusion Criteria

• •1. The subject has a history of any severe anaphylactic reaction to blood or any blood-derived product.
• •2. The subject is known to be intolerant to any component of GAMMAPLEX, such as sorbitol (i.e.(id est / that is) , intolerance to fructose).
• •3. The subject has selective immunoglobulin A (IgA) deficiency, history of reaction to products containing IgA, or has a history of antibodies to IgA.
• •4. Subjects who have completed the study and subjects who have withdrawn cannot participate in the study for a second time.
• •5. 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.
• •6. 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 or an ISG product that is in Phase III or IIIb studies.
• •7. The subject is pregnant or is nursing.
• •8. The subject is positive for any of the following at screening:
• •* Serological test for Human immunodeficiency virus (HIV) 1\&2, Hepatitis C virus (HCV), or Hepatitis B surface antigen (HBsAg)
• •* Nucleic Acid test (NAT) for HCV
• •* NAT for HIV
• •9. 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)
• •10. The subject has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or Blood urea nitrogen (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.
• •11. The subject is known to abuse alcohol, opiates, psychotropic agents, or other chemicals or drugs, or has done so within the past 12 months.
• •12. The subject has a history of deep vein thrombosis (DVT), or thrombotic complications of IGIV therapy.
• •13. The subject suffers from any acute or chronic medical condition (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing state) that, in the opinion of the investigator, may interfere with the conduct of the study.
• •14. The subject has an acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (Absolute neutrophil count (ANC) \< 1000 x 109/L).
• •15. The subject is receiving the following medication:
• •* Immunosuppressive drugs
• •* The subject is receiving the following medication: Steroids (long-term daily, \>0.15 mg /kg/day of prednisone or prednisolone of equivalent dose of other corticosteroids) The requirement for burst or intermittent courses would not exclude the subject.
• •* Immunomodulatory drugs
• •16. The subject has non-controlled arterial hypertension (systolic blood pressure \> 160 mmHg (millimeters of mercury) and/or diastolic blood pressure \> 100 mmHg).
• •17. The subject has anemia (hemoglobin \< 10 g/dL) at screening.