A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
NCT ID: NCT07194070
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
175 participants
OBSERVATIONAL
2025-11-28
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Participants at Risk for Hemolytic Disease of the Fetus and Newborn (HDFN)
Pregnant participants with a risk for HDFN in their current pregnancy will be enrolled. No treatment will be provided by the sponsor as a part of this study. Only data will be collected for participants for the duration of their pregnancy and for 2 years following birth for their corresponding neonate/infant/child. Data will be collected from eligible participants at medical centers that routinely diagnose and treat pregnant participants with HDFN. Additionally, participants will be asked to complete versions of clinical outcome assessments (Patient-reported outcomes \[PROs\]/Observer-reported outcomes \[ObsROs\]) at specific times throughout follow-up. Data collection will be considered complete for eligible participants if all available data have been recorded in the electronic case report form (eCRF).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* History of a previous alloimmunized pregnancy that included at least one of the following: Fetal anemia diagnosed by middle cerebral artery (MCA) doppler ultrasound; Received greater than or equal to (\>=) 1 intrauterine transfusion (IUT) as a result of hemolytic disease of the fetus and newborn (HDFN); Fetal hydrops; Stillbirth or fetal demise with fetal or placental pathology indicative of HDFN; Neonatal exchange transfusion due to HDFN; Neonatal simple transfusion due to HDFN; Neonatal hyperbilirubinemia due to HDFN; Positive direct antiglobulin test (DAT) in neonate
* Documented presence of maternal alloantibody based on local laboratory results during current pregnancy
* Evidence of an antigen-positive fetus corresponding to the current maternal alloantibody: Fetal antigen status confirmed by cell-free fetal DNA (cffDNA); OR Fetal antigen status confirmed by amniocentesis; OR Paternal genotype confirmed
* Pregnant participant or a legally acceptable representative has provided informed consent (per local regulations or ethics committee requirements) for the collection and use of their medical data and the medical data for their corresponding fetuses/neonates/infants/children
Exclusion Criteria
* At risk for HDFN due to ABO being the sole alloimmunization antigen in the current pregnancy (that is, ABO plus another antigen is permissible)
18 Years
FEMALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Interdiszip Schwerpunkt fur Hamostaseologie
Giessen, , Germany
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, , Italy
Countries
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Central Contacts
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Other Identifiers
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NOPRODEBF0001
Identifier Type: OTHER
Identifier Source: secondary_id
NOPRODEBF0001
Identifier Type: -
Identifier Source: org_study_id