Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Janssen Research & Development, LLC
Summary
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).
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
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 con…
Interventions
- DrugNipocalimab
Nipocalimab will be administered intravenously.
- DrugIntravenous immunoglobulins (IVIG)
IVIG will be administered intravenously.
- DrugPrednisone
Prednisone will be administered orally.
Locations (24)
- The University of Alabama at BirminghamBirmingham, Alabama
- UC Davis School of MedicineSacramento, California
- Childrens Hospital ColoradoAurora, Colorado
- Advocate Children's HospitalPark Ridge, Illinois
- University of Iowa Hospital and ClinicsIowa City, Iowa
- University of North Carolina at Chapel HillChapel Hill, North Carolina