A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Recruiting
Phase 3
Interventional Study
Thrombocytopenia, Neonatal Alloimmune
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 39 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
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About This Trial
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
* Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count les…
Contacts