A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-3)
Last Updated May 14, 2025
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80202135FNAIT3003
OVERVIEW
-
Sexes Eligible for Study
female -
Age
years -
Phase
phase 3 -
Sites
Sites -
Status
Recruiting
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).
CONDITIONS
- Thrombocytopenia, Neonatal Alloimmune
ELIGIBILITY
Inclusion Criteria:
* Pregnant and an estimated gestational age from week 13 to 18 at visit 1
* Has a history of greater than or equal to (>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (<) 150*10^9/Liter with no fetal/ne
DETAILS
LOCATIONS
| Country (4) | City or Province (12) | Status |
| Austria | Graz Medizinische Universitaet Graz |
RECRUITING
|
| Germany | Giessen Universitaetsklinikum Giessen und Marburg GmbH |
RECRUITING
|
| Poland | Lodz Instytut Centrum Zdrowia Matki Polki |
RECRUITING
|
| Poland | Warszawa Instytut Matki i Dziecka |
RECRUITING
|
| Poland | Warszawa Panstwowy Instytut Medyczny MSWiA w Warszawie |
RECRUITING
|
| United Kingdom | Birmingham Birmingham Women's Hospital |
RECRUITING
|
| United Kingdom | Liverpool Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital |
RECRUITING
|
| Austria | Vienna Medical University Vienna |
RECRUITING
|
| Germany | Jena Universitatsklinikum Jena |
RECRUITING
|
| Germany | Tuebingen Universitaetsklinikum Tuebingen |
RECRUITING
|
| United Kingdom | London Queen Charlotte's and Chelsea Hospital |
RECRUITING
|
| United Kingdom | Oxford John Radcliffe Hospital |
RECRUITING
|
47.06667, 15.45
50.58727, 8.67554
51.75, 19.46667
52.22977, 21.01178
52.22977, 21.01178
52.48142, -1.89983
53.41058, -2.97794
48.20849, 16.37208
50.92878, 11.5899
48.52266, 9.05222
51.50853, -0.12574
51.75222, -1.25596
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