Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
Official title: Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-02-10
Completion Date
2029-12-11
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Nipocalimab
Nipocalimab will be administered intravenously.
Intravenous immunoglobulins (IVIG)
IVIG will be administered intravenously.
Prednisone
Prednisone will be administered orally.
Locations (38)
The University of Alabama at Birmingham
Birmingham, Alabama, United States
UC Davis School of Medicine
Sacramento, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
University of Florida at Shands
Gainesville, Florida, United States
Advocate Children's Hospital
Park Ridge, Illinois, United States
Riley Children s Hospital
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Wayne State University
Detroit, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health And Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Medizinische Universitaet Graz
Graz, Austria
Medical University Vienna
Vienna, Austria
Universitair Ziekenhuis Leuven
Leuven, Belgium
Charite Universitaetsmedizin Berlin
Berlin, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitatsklinikum Jena
Jena, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Sheba Medical Center
Ramat Gan, Israel
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
Leiden University Medical Center
Leiden, Netherlands
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
Instytut Matki i Dziecka
Warsaw, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie
Warsaw, Poland
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, Slovakia
Univerzitetni klinicni center Ljubljana
Ljubljana, Slovenia
Birmingham Women's Hospital
Birmingham, United Kingdom
Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
Liverpool, United Kingdom
Queen Charlotte's and Chelsea Hospital
London, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom