A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-1)

Last Updated   May 14, 2025

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80202135FNAIT3001

OVERVIEW

  • Sexes Eligible for Study
    female
  • Age
    18+ years
  • Phase
    phase 3
  • Sites
    20 Sites
  • Status
     Recruiting

SUMMARY

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

CONDITIONS

  • Thrombocytopenia, Neonatal Alloimmune

ELIGIBILITY


Inclusion Criteria:

* Has a history of greater than or equal to (>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (<) 150×10^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (I

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DETAILS

LOCATIONS

Locations in:
Belgium, Italy, Norway, Slovakia, Spain, Sweden, Brazil, France, Hungary, Slovenia, Switzerland, Israel
Country (12) City or Province (20) Status
Belgium Leuven Universitair Ziekenhuis Leuven
RECRUITING
Italy Rome Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Norway Bergen Haukeland University Hospital
RECRUITING
Norway Oslo Oslo University Hospital HF Ulleval sykehus
RECRUITING
Slovakia Kosice Univerzitna nemocnica L. Pasteura Kosice
RECRUITING
Slovakia Martin Univerzitná nemocnica Martin
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
Sweden Stockholm Karolinska Universitetssjukhuset Huddinge
RECRUITING
Brazil Recife Instituto de Medicina Integral Professor Fernando Figueira
RECRUITING
Brazil Rio de Janeiro Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Brazil Sao Paulo Hospital Das Clinicas Da Faculdade De Medicina Da USP
RECRUITING
France Lille CHRU Lille
RECRUITING
France Paris Hopital trousseau- APHP
RECRUITING
Hungary Budapest Semmelweis Egyetem
RECRUITING
Norway Tromso Universitetssykehuset Nord-Norge HF
RECRUITING
Norway Trondheim St. Olavs Hospital
RECRUITING
Slovenia Ljubljana Univerzitetni klinicni center Ljubljana
RECRUITING
Switzerland Lausanne Centre Hospitalier Universitaire Vaudois CHUV
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Slovakia Nove Zamky Fakultna nemocnica s poliklinikou Nove Zamky
RECRUITING
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Geo Locations

50.87959, 4.70093

41.89193, 12.51133

60.39299, 5.32415

59.91273, 10.74609

48.71395, 21.25808

49.06651, 18.92399

37.38283, -5.97317

59.33258, 18.0649

-8.05389, -34.88111

-22.90278, -43.2075

-23.5475, -46.63611

50.63297, 3.05858

48.85341, 2.3488

47.49801, 19.03991

69.6489, 18.95508

63.43049, 10.39506

46.05108, 14.50513

46.516, 6.63282

32.08227, 34.81065

47.98544, 18.16195

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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