Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Спонсор: Janssen Cilag International
Налично на:
БГ
Обобщение
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
Кой може да участва
Age group: 18-64 years
Gender: Female
Target enrollment: 13 participants
Интервенции
PREDNISONE
Drug
PREDNISONE
Drug
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Drug
Imaavy 185 mg/mL concentrate for solution for infusion