Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Спонсор: Janssen - Cilag International
Налично на:
БГ
Обобщение
Trial status: Authorised
Platelet count at birth in a neonate, Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate
Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth <30×10⁹/l in a fetus/neonate.
Описание
Platelet count at birth in a neonate, Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate
Кой може да участва
Age group: 18-64 years
Gender: Female
Target enrollment: 27 participants
Интервенции
Saline, 0.9% Sodium Chloride Solution for Injection
БГ
EN