Status:
RECRUITING
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Hemolytic Disease of the Fetus and Newborn
Eligibility:
FEMALE
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Pregnant with an estimated gestational age (GA) (based on ultrasound dating) up to week 24
- 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
- Participant actively participating in an interventional trial of an investigational agent
- At risk for HDFN due to ABO being the sole alloimmunization antigen in the current pregnancy (that is, ABO plus another antigen is permissible)
Key Trial Info
Start Date :
December 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT07194070
Start Date
December 31 2025
End Date
September 30 2030
Last Update
December 19 2025
Active Locations (4)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
2
Baylor College of Medicine
Houston, Texas, United States, 77030
3
Interdiszip Schwerpunkt fur Hamostaseologie
Giessen, Germany, 35392
4
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00137