A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases

Exclusion Criteria

• •Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
• •Exposure to blood or any blood product or derivative, other than commercially available intravenous immunoglobulin (IVIG), within the past 3 months prior to enrollment.
• •Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product.
• •Requirement of any routine pre-medication for IVIG infusion.
• •Severe liver function impairment (alanine aminotransferase \[ALAT\] 3x \> upper limit of normal).
• •Presence of renal function impairment (creatinine \> 120 μmol/L), or predisposition for acute renal failure (eg, any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
• •History of autoimmune hemolytic anemia.
• •History of diabetes mellitus.
• •Congestive heart failure New York Heart Association (NYHA) class III or IV.
• •Non-controlled arterial hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 90 mmHg).
• •History of deep vein thrombosis or thrombotic complications of IVIG therapy.
• •A positive result at screening on any of the following viral markers: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV).
• •Treatment with steroids (oral or parenteral, long-term, ie, 30 days or more, not intermittent or burst, daily, ≥ 0.15 mg of prednisone or equivalent/kg/day), immunosuppressive or immunomodulatory drugs.
• •Planned vaccination during the study period.
• •Treatment with any investigational agent within 3 months prior to enrollment.
• •Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to enrollment.
• •Pregnant or nursing women.