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A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Sponsor: Janssen Research & Development, LLC
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.
Official title: Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
175
Start Date
2025-02-20
Completion Date
2030-09-30
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Standard 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 (10)
Riley Children s Hospital
Indianapolis, Indiana, 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
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
Birmingham Women's Hospital
Birmingham, United Kingdom