NCT07194070

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

Global Prospective Hemolytic Disease of the Fetus and Newborn Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 175 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemolytic Disease of the Fetus and Newborn

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-17
• Primary completion: 2030-05-26
• Completion: 2030-09-30
• First posted: 2025-09-26
• Last updated: 2026-04-13

Locations

10 sites across 5 countries: United States, Australia, Germany, Italy, United Kingdom