A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Summary

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

Timeline

Start

2023-12-20

Primary completion

2027-08-05

Completion

2029-10-08

Publications

• Rego S, Ashimi Balogun O, Emanuel K, Overcash R, Gonzalez JM, Denomme GA, Hoskovec J, King H, Wilson A, Wynn J, Moise KJ Jr. Cell-Free DNA Analysis for the Determination of Fetal Red Blood Cell Antigen Genotype in Individuals With Alloimmunized Pregnancies. Obstet Gynecol. 2024 Oct 1;144(4):436-443. doi: 10.1097/AOG.0000000000005692. Epub 2024 Jul 25.

Drugs

Indications