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New drug could shield unborn babies from deadly bleeding disorder

NCT ID NCT06449651

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

First seen Oct 01, 2025 · Last updated May 14, 2026 · Updated 33 times

Summary

This study tests a drug called nipocalimab to see if it can prevent severe bleeding or death in unborn babies with a rare condition called FNAIT, where the mother's immune system attacks the baby's platelets. Pregnant women who have had a previous pregnancy affected by FNAIT are given either the drug or a placebo from weeks 13-18 of pregnancy. The goal is to see if the drug reduces the risk of severe bleeding or low platelet counts in the newborn.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

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

    RECRUITING

    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

Conditions

Explore the condition pages connected to this study.

THROMBOCYTOPENIA, NEONATAL ALLOIMMUNE