placebo + human normal immunoglobulin

Placebo + IVIG refers to the active comparator arm (Regimen A) in the randomized, double-blind, Phase 3 clinical trial NCT00376077 conducted by The Hospital for Sick Children (SickKids). This regimen was used as a control to evaluate whether the addition of high-dose intravenous methylprednisolone (IVMP) to intravenous immunoglobulin (IVIG) could more rapidly increase platelet counts in children with immune thrombocytopenic purpura (ITP). The arm consists of a saline placebo infusion (0.9% NaCl) followed by a 1 g/kg dose of IVIG (specifically the brand Gammunex). IVIG is a biologic product derived from pooled human plasma containing polyclonal IgG. Its mechanism of action in ITP involves the modulation of Fc receptor-mediated clearance of antibody-coated platelets by splenic macrophages, as well as broader immunomodulatory effects such as neutralizing autoantibodies and inflammatory cytokines.

Brand names

Gammunex

Other names

IVIGintravenous immunoglobulinhuman normal immunoglobulinplacebo + IVIG