Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)
Erythroblastosis, Fetal
Eligibility:
FEMALE
18+ years
Brief 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 dise...
Detailed Description
The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
Eligibility Criteria
Inclusion
- Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Exclusion
Key Trial Info
Start Date :
January 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03755128
Start Date
January 16 2019
End Date
September 22 2023
Last Update
September 12 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center
New York, New York, United States, 10032
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267
3
Oregon Health and Science University
Portland, Oregon, United States, 97239
4
UPMC
Pittsburgh, Pennsylvania, United States, 15213