RecruitingNCT07194070

A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Global Prospective Hemolytic Disease of the Fetus and Newborn Registry

Sponsor

Janssen Research & Development, LLC

Enrollment

175 participants

Start Date

Dec 17, 2025

Study Type

OBSERVATIONAL

Conditions

Hemolytic Disease of the Fetus and Newborn

Summary

The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk for hemolytic disease of the fetus and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that occurs in babies before birth or just after birth when the blood types of the pregnant individual and babies are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus/baby.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard of Care for people with hemolytic disease of the fetus and newborn. The study is currently recruiting participants at 14 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard of Care

No study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice.

Locations(15)

Riley Children s Hospital

Indianapolis, Indiana, United States

University of Rochester Medical Center

Rochester, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health And Science University

Portland, Oregon, United States

Baylor College of Medicine

Houston, Texas, United States

The Royal Women's Hospital

Parkville, Australia

Mater Misericordiae Ltd

South Brisbane, Australia

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

State University of Campinas Joao Bennini

Campinas, Brazil

Interdiszip Schwerpunkt fur Hamostaseologie

Giessen, Germany

Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

Milan, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Hosp Univ Vall D Hebron

Barcelona, Spain

Birmingham Women's Hospital

Birmingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07194070

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