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Design of a Phase 3, Global, Multicenter, Randomized, Placebo-controlled, Double-blind Study of Nipocalimab in Pregnancies At-risk for Severe Hemolytic Disease of the Fetus and Newborn

Yosuke Komatsu,E. J. T. (Joanne) Verweij,Eleonor Tiblad,Enrico Lopriore,Dick Oepkes, Prasheen Agarwal,Edwin Lam,Jocelyn H. Leu,Leona E. Ling, Leona E. Nelson, Victor Olusajo,Shumyla Saeed-Khawaja,May Lee Tjoa, Jie Zhou, Umair Amin, Waheeda Sirah,Kenneth J. Moise Jr

AMERICAN JOURNAL OF PERINATOLOGY(2024)

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Key words
neonatal Fc receptor blocker,nipocalimab,hemolytic disease of the fetus and newborn,HDFN,intrauterine transfusion,red blood cell alloimmunization,safety,efficacy,study design
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