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A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.
Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-12-20
Completion Date
2029-07-10
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Nipocalimab
Nipocalimab will be administered as an intravenous infusion.
Placebo
Placebo will be administered as an intravenous infusion.
Locations (59)
University of California at San Diego
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
UC Davis School of Medicine
Sacramento, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Advocate Children's Hospital
Park Ridge, Illinois, United States
Riley Children s Hospital
Indianapolis, Indiana, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Midwest Fetal Care Center
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina (UNC) - School of Medicine
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
University of Texas Dell Medical School Department of Women's Health
Austin, Texas, United States
University Of Texas Medical Branch At Galveston
Galveston, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Privado Universitario De Cordoba
Córdoba, Argentina
Mater Hospital Brisbane
South Brisbane, Australia
Liverpool Hospital
Sydney, Australia
Medizinische Universitaet Wien
Vienna, Austria
C.H.U. Brugmann
Brussels, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Universidade Federal De Minas Gerais
Belo Horizonte, Brazil
Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG
Goiânia, Brazil
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
BC Women's Hospital University of British Columbia
Vancouver, British Columbia, Canada
Centre Hospitalier Sainte Justine
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron, France
CHRU Lille
Lille, France
Hopital Armand Trousseau
Paris, France
Charite Universitaetsmedizin Berlin
Berlin, Germany
Universitaetsklinikum Giessen und Marburg Standort Giessen
Giessen, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany
Rotunda Hospital
Dublin, Ireland
Hadassah mount scopus
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
Kyushu University Hospital
Fukuoka, Japan
Gifu Prefectural General Medical Center
Gifu, Japan
Osaka Women's and Children's Hospital
Izumi-shi, Japan
Toho University Medical Center Omori Hospital
Ōta-ku, Japan
Miyagi Children's Hospital
Sendai, Japan
Leiden University Medical Center
Leiden, Netherlands
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Univ. La Paz
Madrid, Spain
Hosp. Virgen Del Rocio
Seville, Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Birmingham Women's Hospital
Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Kings College Hospital
London, United Kingdom
St Georges Hospital
London, United Kingdom
St.Mary's Hospital
Manchester, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom