Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
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.