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
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
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.
Description
Platelet count at birth in a neonate, Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate
Who can participate
Age group: 18-64 years
Gender: Female
Target enrollment: 27 participants
Interventions
Saline, 0.9% Sodium Chloride Solution for Injection
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