Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Phase 3 – large-scale trial before approval
Conditions:
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Sponsor: Janssen Cilag International
trial.available_in:
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Overview
Trial status: Authorised
Adverse outcome of death or adjudicated severe bleeding in utero, and up to the first week post birth, or platelet count at birth <30×10^9/L in a fetus/neonate
Who can participate
Age group: 18-64 years
Gender: Female
Target enrollment: 13 participants
Interventions
PREDNISONE
Drug
PREDNISONE
Drug
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Drug
Imaavy 185 mg/mL concentrate for solution for infusion
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