31
Participants
Start Date
July 18, 2025
Primary Completion Date
August 27, 2026
Study Completion Date
February 27, 2027
5% (5g/100 ml) intravenous immunoglobin
"A 5% human normal immunoglobulin I.P. (5 g/100 mL) V-IMMUNE® will be administered at a dose of 1 g/kg, intravenously, once daily for 2 consecutive days (Day 1 and Day 2). The infusion rate starts at 0.01 mL/kg/min during the first 30 minutes and is gradually increased up to 0.06 mL/kg/min if no adverse events occur. This will constitute the first cycle of V-IMMUNE® treatment. The dose of 1 g/kg/day on 2 consecutive days is consistent with recommendations for the use of other IVIG products in Immune Thrombocytopenia.~If the platelet count is not maintained for the desired duration after the first V-IMMUNE® cycle, and at the discretion of the investigator and the patient/legal representative, participants may receive up to one additional cycle of V-IMMUNE®-at the same dosing regimen used in Cycle 1-between Day 15 and Day 30"
NOT_YET_RECRUITING
IMIP Instituto de Medicina Integral Professor Fernando Figueira, Recife
RECRUITING
Santa Casa de Misericórida de São Paulo, São Paulo
Hospital do Coracao
OTHER
On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
OTHER