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New drug aims to prevent deadly bleeding in unborn babies

NCT ID NCT06449651

Recruiting now Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests a medicine called nipocalimab to see if it can lower the risk of severe bleeding or death in unborn babies with a rare condition called FNAIT. The study includes 39 pregnant women who have had a previous pregnancy affected by FNAIT. Participants receive either nipocalimab or a placebo during pregnancy, and the health of the baby is monitored after birth.

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Conditions

The condition(s) this trial relates to.

neonatal thrombocytopenia fetal and neonatal alloimmune thrombocytopenia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

THROMBOCYTOPENIA, NEONATAL ALLOIMMUNE

Contacts and locations

Locations

  • CHRU Lille

    RECRUITING

    Lille, 59000, France

  • Centre Hospitalier Universitaire Vaudois CHUV

    RECRUITING

    Lausanne, 1011, Switzerland

  • Fakultna nemocnica s poliklinikou Nove Zamky

    RECRUITING

    Nové Zámky, 940 34, Slovakia

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

  • Haukeland University Hospital

    RECRUITING

    Bergen, 5009, Norway

  • Hopital trousseau- APHP

    RECRUITING

    Paris, 75012, France

  • Hosp. Virgen Del Rocio

    COMPLETED

    Seville, 41013, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    RECRUITING

    São Paulo, 05403 000, Brazil

  • Instituto D Or de Pesquisa e Ensino IDOR

    RECRUITING

    Rio de Janeiro, 22281 00, Brazil

  • Instituto de Medicina Integral Professor Fernando Figueira

    RECRUITING

    Recife, 50070-902, Brazil

  • Karolinska Universitetssjukhuset Huddinge

    RECRUITING

    Stockholm, SE-141 86, Sweden

  • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Oslo University Hospital HF Ulleval sykehus

    RECRUITING

    Oslo, 0455, Norway

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1082, Hungary

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262000, Israel

  • St. Olavs Hospital

    RECRUITING

    Trondheim, 7030, Norway

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitetssykehuset Nord-Norge HF

    RECRUITING

    Tromsø, 9019, Norway

  • Univerzitetni klinicni center Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

  • Univerzitna nemocnica L. Pasteura Kosice

    RECRUITING

    Košice, 04190, Slovakia

  • Univerzitná nemocnica Martin

    RECRUITING

    Martin, 036 01, Slovakia

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