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M281 in Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
NCT03842189Phase 2Completed
- Sponsor
- Janssen Pharmaceutical
- Start
- Apr 2018
- Primary completion
- Aug 2024
- Modality
- Monoclonal Antibodies
- Countries
- 9
01
Overview
Phase 2, open-label, single-arm trial of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), sponsored by Janssen Pharmaceutical. Primary endpoints: Number of Maternal Participants With Treatment-emergent Adverse Events, Number of Neonates/Infants With Adverse Events and 1 more. Started Apr 2018; status: completed.
02
Drugs
nipocalimab
03
Conditions
hemolytic disease of the fetus and newborn (HDFN)
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