A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Condition(s) studied
Investigational drug(s) / intervention(s)
Nipocalimab: Nipocalimab will be administered intravenously.
Intravenous immunoglobulins (IVIG): IVIG will be administered intravenously.
Prednisone: Prednisone will be administered orally.
Study summary
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
Eligibility
Primary outcome measure(s)
- Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L — Up to 1 Week post birth
Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count \<30\*10\^9/L will be reported.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| UC Davis School of Medicine | Sacramento | California | Recruiting |
| Childrens Hospital Colorado | Aurora | Colorado | Recruiting |
| Advocate Children's Hospital | Park Ridge | Illinois | Recruiting |
| Riley Children s Hospital | Indianapolis | Indiana | Suspended |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | Recruiting |
| University of Rochester Medical Center | Rochester | New York | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| Oregon Health And Science University | Portland | Oregon | Recruiting |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| University of Texas Medical Branch | Galveston | Texas | Recruiting |
| University of Utah | Salt Lake City | Utah | Recruiting |
| Medizinische Universitaet Graz | Graz | Austria | Recruiting |
| Medical University Vienna | Vienna | Austria | Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH | Giessen | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| Universitatsklinikum Jena | Jena | Germany | Recruiting |
| Universitaetsklinikum Tuebingen | Tübingen | Germany | Recruiting |
| Sheba Medical Center | Ramat Gan | Israel | Recruiting |
| Leiden University Medical Center | Leiden | Netherlands | Recruiting |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Poland | Recruiting |
| Instytut Matki i Dziecka | Warsaw | Poland | Recruiting |
| Panstwowy Instytut Medyczny MSWiA w Warszawie | Warsaw | Poland | Recruiting |
| Birmingham Women's Hospital | Birmingham | United Kingdom | Recruiting |
| Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital | Liverpool | United Kingdom | Recruiting |
| Queen Charlotte's and Chelsea Hospital | London | United Kingdom | Recruiting |
| John Radcliffe Hospital | Oxford | United Kingdom | Recruiting |
On this site
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06533098 on ClinicalTrials.gov ↗ ← All trials in Poland