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A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Sponsor: Janssen Research & Development, LLC
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).
Official title: Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2024-11-11
Completion Date
2029-12-05
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Placebo will be administered intravenously.
Locations (21)
Universitair Ziekenhuis Leuven
Leuven, Belgium
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil
CHRU Lille
Lille, France
Hopital trousseau- APHP
Paris, France
Semmelweis Egyetem
Budapest, Hungary
Sheba Medical Center
Ramat Gan, Israel
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Rome, Italy
Haukeland University Hospital
Bergen, Norway
Oslo University Hospital HF Ulleval sykehus
Oslo, Norway
Universitetssykehuset Nord-Norge HF
Tromsø, Norway
St. Olavs Hospital
Trondheim, Norway
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia
Univerzitná nemocnica Martin
Martin, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, Slovakia
Univerzitetni klinicni center Ljubljana
Ljubljana, Slovenia
Hosp. Virgen Del Rocio
Seville, Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland