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Nipocalimab versus IVIG in pregnancies at risk of fetal and neonatal alloimmune thrombocytopenia
2023-509434-19-00Phase 3Authorised
- Sponsor
- Janssen Pharmaceutical
- Start
- Feb 2025
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Countries
- 13
01
Overview
Phase 3, randomised, open-label trial of nipocalimab and subcuvia in fetomaternal alloimmune thrombocytopenia (FMAIT) (2 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Composite adverse fetal/neonatal outcome. Planned start Feb 2025; status: authorised.
02
Drugs
nipocalimabsubcuvia
03
Conditions
fetomaternal alloimmune thrombocytopenia (FMAIT)
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