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RECRUITING
NCT07194070

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

OTHER

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