Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Exclusion Criteria

• •Subjects must be excluded if they meet any of the following criteria:
• •1. Have a known hypersensitivity to immunoglobulin or any excipient in RI-002.
• •2. Have a history of a severe anaphylactic or anaphylactoid reaction to blood or any blood-derived product.
• •3. Have a specific Immunoglobulin A (IgA) deficiency, history of allergic reaction to products containing IgA or has demonstrable antibodies to IgA.
• •4. Have uncompensated hemodynamically significant congenital or other heart disease.
• •5. Have a medical condition that is known to cause secondary immune deficiency.
• •6. Have a significant T-cell deficiency or deficiency of granulocyte number or function.
• •7. Have significant renal impairment or have a history of acute renal failure.
• •8. Have abnormal liver function.
• •9. Be receiving chronic anti-coagulation therapy.
• •10. Have a history of deep vein thrombosis (DVT), thrombotic or thrombo-embolic event, or are at increased risk for thrombotic events.
• •11. Current daily use of the following medications:
• •* corticosteroids (\> 7.5 mg (or equivalent dose on a mg/kg basis) of prednisone equivalent per day for \> 30 days)
• •* immunomodulatory drugs
• •* immunosuppressive drugs (excluding topical pimecrolimus (Elidel) and tacrolimus (Protopic))
• •12. Administration of a hyperimmune or specialty high titer immunoglobulin product.
• •13. Have uncontrollable arterial hypertension.
• •14. Have a history of hemolysis or positive Coombs test while undergoing treatment with IGIV therapy.
• •15. Be morbidly obese as indicated by a Body Mass Index (BMI) ≥ 40
• •16. Have received any blood product (other than Immunoglobulin G) within 3 months prior to screening.
• •17. Have received any Respiratory Syncytial Virus (RSV) specific products, including palivizumab (Synagis®) within 3 months prior to screening.
• •18. Have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
• •19. Have any condition or abnormal laboratory assessment judged by the investigator to preclude participation in the study.
• •20. Are currently pregnant or nursing.
• •21. Have hepatitis A, B, or C.