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A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn

NCT03755128 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2025-09-12

No results posted yet for this study

Summary

The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

Conditions

  • Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)
  • Erythroblastosis, Fetal

Interventions

OTHER

No intervention

No investigational drugs will be administered as part of the study

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
2019-01-16
Primary Completion
2023-09-22
Completion
2023-09-22

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Netherlands
  • Spain
  • Sweden
  • 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 NCT03755128 on ClinicalTrials.gov