The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Tampere University Hospital
Tampere, Finland
Turku University Central Hospital
Turku, Finland
SU/Sahlgrenska
Gothenburg, Sweden
University Hospital Lund
Lund, Sweden
University Hospital MAS
Malmo, Sweden
Sundsvall Hospital
Sundsvall, Sweden
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
Time frame: 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit
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