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RECRUITING
NCT05912517
PHASE3

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

DRUG

Nipocalimab

Nipocalimab will be administered as an intravenous infusion.

DRUG

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