A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Start Date
12/20/2023
Completion Date
10/8/2029
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.
Eligibility Criteria
Age Range: 18 years to 45 years
Interventions
Nipocalimab
Placebo
Conditions
Locations
University of California at San Diego
La Jolla, California 92037
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
UC Davis School of Medicine
Sacramento, California 95817
United States
Childrens Hospital Colorado
Aurora, Colorado 80045
United States
University of Miami
Miami, Florida 33136
United States
Advocate Children's Hospital
Park Ridge, Illinois 60068
United States
Riley Children s Hospital
Indianapolis, Indiana 46202
United States
University of Kentucky Medical Center
Lexington, Kentucky 40536
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Boston Childrens Hospital
Boston, Massachusetts 02115
United States
Midwest Fetal Care Center
Minneapolis, Minnesota 55404
United States
Columbia University Medical Center
New York, New York 10032
United States
University of North Carolina (UNC) - School of Medicine
Chapel Hill, North Carolina 27599-7516
United States
University of Cincinnati
Cincinnati, Ohio 45267
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Lehigh Valley Hospital
Allentown, Pennsylvania 18103-6218
United States
University of Texas Dell Medical School Department of Women's Health
Austin, Texas 78723
United States
University Of Texas Medical Branch At Galveston
Galveston, Texas 77555
United States
Intermountain Medical Center
Murray, Utah 84107
United States
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia 23507
United States
Hospital Italiano de Buenos Aires
Buenos Aires, C1199
Argentina
Hospital Privado Universitario De Cordoba
Córdoba, X5016KEH
Argentina
Mater Hospital Brisbane
South Brisbane, 4101
Australia
Liverpool Hospital
Sydney, 2170
Australia
Medizinische Universitaet Graz
Graz, 8036
Austria
Medizinische Universitaet Wien
Vienna, 1090
Austria
C.H.U. Brugmann
Brussels, 1020
Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000
Belgium
Universidade Federal De Minas Gerais
Belo Horizonte, 30130100
Brazil
Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG
Goiânia, 74605-050
Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, 50070902
Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, 22281 100
Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403-010
Brazil
BC Women's Hospital University of British Columbia
Vancouver, British Columbia V6H 3N1
Canada
Mount Sinai Hospital
Toronto, Ontario M5G 1X5
Canada
Centre Hospitalier Sainte Justine
Montreal, Quebec H3T 1C5
Canada
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron, 69500
France
CHRU Lille
Lille, 59000
France
Hopital Armand Trousseau
Paris, 75012
France
Charite Universitaetsmedizin Berlin
Berlin, 10117
Germany
Universitaetsklinikum Giessen und Marburg Standort Giessen
Giessen, 35392
Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20251
Germany
Rotunda Hospital
Dublin, D01 P5W9
Ireland
Hadassah mount scopus
Jerusalem, 91240
Israel
Rabin Medical Center
Petah Tikva, 49100
Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Israel
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
Italy
Kyushu University Hospital
Fukuoka, 812 8582
Japan
Gifu Prefectural General Medical Center
Gifu, 500-8717
Japan
Osaka Womens and Childrens Hospital
Izumi-shi, 594-1101
Japan
Toho University Medical Center Omori Hospital
Ōta-ku, 143-8541
Japan
Miyagi Childrens Hospital
Sendai, 989-3126
Japan
Leiden University Medical Center
Leiden, 2333 ZA
Netherlands
Hosp Univ Vall D Hebron
Barcelona, 08035
Spain
Hosp. Univ. La Paz
Madrid, 28046
Spain
Hosp. Virgen Del Rocio
Seville, 41013
Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, 14186
Sweden
Birmingham Women's Hospital
Birmingham, B15 2TG
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United Kingdom
Kings College Hospital
London, SE5 9RS
United Kingdom
St Georges Hospital
London, SW17 0QT
United Kingdom
St.Mary's Hospital
Manchester, M13 9WL
United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU
United Kingdom