Overview

Principal investigator

Mark Santillan
Obstetrics/Gynecology

Eligibility criteria

Inclusion Criteria:
*  Pregnant and an estimated gestational age from week 13 to 18 at visit 1
*  Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (\<) 150\
* 10\^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
*  Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood
*  Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
*  For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion Criteria:
*  Currently pregnant with multiple gestations (twins or more)
*  History of severe preeclampsia in a previous pregnancy
*  History of myocardial infarction, unstable ischemic heart disease, or stroke
*  Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone
*  Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
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For Referring Providers

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Contact the study coordinator

Mark Santillan
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