- A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) — Recruiting • Phase III • NCT05912517.
- Nipocalimab versus placebo for preventing severe haemolytic disease in at-risk pregnancies.
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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. Conditions: Hemolytic Disease of the Fetus and Newborn Interventions: Nipocalimab, Placebo Lead Sponsor: Janssen Research & Development, LLC Planned Enrollment: 120 participants