Primary Immunodeficiency Clinical Trial
Official title:
Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml
Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.
n/a
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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