Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% 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 has selective IgA deficiency, history of reaction to products containing IgA (Immunoglobulin A), or has a history of antibodies to IgA.
• •3. The subject has cellular or innate impaired immunity (i.e. only subjects with humoral impaired immunity may be included).
• •4. The subject has evidence of an active infection at the time of enrolment.
• •5. The subject has previously completed or withdrawn from this study.
• •6. The subject is currently receiving, or has received, any investigational agent other than an IGIV within the prior three months.
• •7. The subject is pregnant or is nursing.
• •8. The subject has positive results for any of the following at Screening:
• •* Serological test for HIV 1 and 2, HCV, or HBsAg
• •* NAT (Nucleic acid amplification technique)for HCV
• •* NAT for HIV
• •9. The subject has levels \> 2.5 times the upper limit of normal, as defined at the central laboratory, of any of the following at Screening:
• •* Alanine amino transaminase
• •* Aspartate amino transaminase
• •10. The subject has severe renal impairment (defined as serum creatinine greater than two times the upper limit of normal or blood urea nitrogen 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 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 the Investigator feels may interfere with the conduct of the study.
• •14. The subject has an acquired immunodeficiency condition such as chronic\* lymphocytic leukemia, lymphoma, multiple myeloma, or chronic or recurrent neutropenia (absolute neutrophil count \< 1 × 109/L).
• •15. The subject is receiving the following medication:
• •* Steroids (long term daily, ≥ 0.15 mg of prednisone equivalent/kg/day). Requirement for short or intermittent courses of steroids would not exclude a subject.
• •* Immunosuppressive drugs
• •* Immunomodulatory drugs
• •16. The subject has uncontrolled arterial hypertension (systolic blood pressure \> 160 mm Hg and/or diastolic blood pressure \> 100 mm Hg).
• •17. The subject has anemia (hemoglobin \< 10 g/dL) at Screening.
• •18. The subject is known to be intolerant to any component of Gammaplex, such as sorbitol (i.e. hereditary intolerance to fructose) or glycine.
• •* Chronic conditions would be as per the Investigator's opinion however for this study the guidance is that the condition has been present for at least 6 months.