A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Recruiting
Phase 3
Interventional Study
Thrombocytopenia, Neonatal Alloimmune
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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
- 50 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
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About This Trial
The purpose of this study is to assess the efficacy and safety of nipocalimab 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) from week 13\* to 18 at visit 1
\*Randomization for high-risk FNAIT participants to occur at GA Week 12
* Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neona…
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