V-IMMUNE® for Immune Thrombocytopenia

PHASE3RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

August 27, 2026

Study Completion Date

February 27, 2027

Conditions
Immune Thrombocytopenia (ITP)
Interventions
BIOLOGICAL

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"

Trial Locations (2)

50070-902

NOT_YET_RECRUITING

IMIP Instituto de Medicina Integral Professor Fernando Figueira, Recife

01221020

RECRUITING

Santa Casa de Misericórida de São Paulo, São Paulo

All Listed Sponsors
collaborator

Hospital do Coracao

OTHER

lead

On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.

OTHER

NCT06962631 - V-IMMUNE® for Immune Thrombocytopenia | Biotech Hunter | Biotech Hunter