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Clinical Trial ● Currently Recruiting Phase III NCT05912517

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

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) — Recruiting • Phase III • NCT05912517.

📅 05 Jun 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT05912517
Start
2023-12-20
Completion
2027-08-05
ClinicaliQ Trial Snapshot
  • 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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What This Trial Is Studying

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

Full Trial Details
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Eligibility criteria, protocol, and results when available
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