Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

Inclusion Criteria: Subjects will be eligible for study entry if they: are at least 18 years old have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening if female of childbearing potential, agree to employ adequate birth control measures during the study have given written informed consent Exclusion Criteria: Subjects will not be eligible for study entry if they: had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study suffer from documented selective IgA deficiency with antibodies against IgA have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.) are known to be infected with HIV, HCV, or HBV are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style suffer from congestive heart failure and receive on-demand treatment with furosemide show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit received another investigational drug in the three weeks preceding study entry in case of females, are pregnant or nursing mothers