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Recruiting NCT06533098

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Conditions: Thrombocytopenia, Neonatal Alloimmune

Sex: Female

Ages: 18 Years – 45 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 50

Sponsor: Janssen Research & Development, LLC

Location: The University of Alabama at Birmingham Birmingham Alabama

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 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) neonatal platelet count less than (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06533098). StuddyBuddy aggregates publicly available trial information.