Blood
Reproductive health and childbirth
Multicentre, Open-Label, Randomised Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-3)
This is a global open-label, randomized, multicenter, interventional study in pregnant participants with a prior FNAIT-affected pregnancy to assess the efficacy, safety, tolerability, PK, PD, and immunogenicity of nipocalimab or IVIG. ‘IVIG’ throughout the protocol will be referring to the IVIG with or without prednisone regimen adapted from Bussel et al (Bussel 2021). The studywill
target participants whose current pregnancies are affected by HPA-1a and/or HPA-5b incompatibility. Maternal participants with alloantibodies against both HPA-1a and HPA-5b will be categorized under HPA-1a ...
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