Drug intelligence / Profile preview

placebo + intravenous immune globulin

Development stage
Unknown
Lead developer
SickKids
Administration
Intravenous
01

Overview

This refers to the control treatment arm of a randomized, double-blind Phase 3 clinical trial (NCT00376077) conducted by The Hospital for Sick Children for the treatment of childhood immune thrombocytopenic purpura (ITP). The regimen consists of an intravenous infusion of a saline placebo (0.9% NaCl) followed immediately by 1 g/kg of intravenous immune globulin (IVIG), specifically the brand Gamunex 10%. IVIG is a biologic product composed of pooled human immunoglobulins that provides rapid immunomodulation. Its primary mechanism in ITP involves the competitive blockade of Fc gamma receptors on splenic macrophages, which prevents the premature destruction of autoantibody-coated platelets. The trial compared this "IVIG alone" approach (with placebo) against a combination of IVIG and high-dose methylprednisolone to determine if the combination could more rapidly augment platelet counts.

Brand names
Gamunex
Other names
Regimen Aplacebo + IVIGIV placebo + IVIG
02

Targets

FCGRT (Neonatal crystallizable fragment receptor)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)

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