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

Last Updated   August 7, 2024

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80202135FNAIT3001

OVERVIEW

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

SUMMARY

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of 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
Country (6) City or Province (8) 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
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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

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50

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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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