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

NCT07194070 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2030-05-26
Completion
2030-09-30

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194070 on ClinicalTrials.gov