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Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

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Trial Profile

Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Immunoglobulins (Primary) ; Nipocalimab (Primary) ; Prednisone (Primary)
  • Indications Neonatal alloimmune thrombocytopenia
  • Focus Therapeutic Use
  • Acronyms FREESIA-3
  • Sponsors Janssen Research & Development

Most Recent Events

  • 31 Jan 2025 Status changed from not yet recruiting to recruiting.
  • 18 Dec 2024 Planned initiation date changed from 13 May 2025 to 19 May 2025.
  • 10 Dec 2024 Trial design presented at the 66th American Society of Hematology Annual Meeting and Exposition.

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