Study of Octanorm Subcutaneous IG in Patients With PID

Exclusion Criteria

• •1. Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
• •2. Known history of adverse reactions to IgA in other products.
• •3. Patients with body mass index ≥40 kg/m2.
• •4. Exposure to blood or any blood product or plasma derivatives, other than IVIG treatment for PID, within the past 3 months prior to the first infusion of octanorm.
• •5. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product (such as Polysorbate 80).
• •6. Requirement of any routine premedication for IgG administration.
• •7. History of malignancies of lymphoid cells and immunodeficiency with lymphoma.
• •8. Severe liver function impairment (ALAT 3 times above upper limit of normal).
• •9. Known protein-losing enteropathies or proteinuria.
• •10. Presence of renal function impairment (creatinine greater than 120 uM/L), or creatinine greater than 1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
• •11. Treatment with oral or parenteral steroids for greater than or equal to 30 days or when given intermittently or as bolus at daily doses greater than or equal to 0.15 mg/kg.
• •12. Treatment with immunosuppressive or immunomodulatory drugs.
• •13. Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of octanorm.
• •14. Treatment with any investigational medicinal product within 3 months prior to first infusion of octanorm.
• •15. Presence of any condition, that is likely to interfere with the evaluation of study medication or satisfactory conduct of the trial.
• •16. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of octanorm.
• •17. Known or suspected HIV, HCV, or HBV infection.
• •18. Pregnant or nursing women.
• •19. Planned pregnancy during the course of the study.