Clin2
NCT06533098Possibly a fitRecruiting

Nipocalimab vs IVIG for FNAIT in pregnancy

Thrombocytopenia, Neonatal Alloimmune

Treatments studied

Part of Blood & lymphatic, Genetic & congenital clinical trials.

This study tests a new medicine called nipocalimab compared to standard IVIG treatment for pregnant women who are at risk of a serious condition where the mother's antibodies attack the baby's platelets (FNAIT). The goal is to see if nipocalimab can prevent complications like bleeding in the baby.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
50 people
Ages
18 years to 45 years
Study type
Interventional

Who can take part

  • You are pregnant and between 13 and 18 weeks (or 12 weeks for high-risk cases).
  • You have had at least one prior pregnancy where the baby had a low platelet count or a brain bleed due to FNAIT.
  • Blood tests in your current pregnancy show you have certain antibodies (HPA-1a or HPA-5b) and the baby's genetic makeup is positive for the related platelet type.
  • You are generally healthy, as confirmed by a doctor's exam and basic lab tests.
  • You are willing to not join any other research study for a new treatment until after your follow-up visits.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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