NCT07194070 A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
| NCT ID | NCT07194070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Hemolytic Disease of the Fetus and Newborn |
| Study Type | OBSERVATIONAL |
| Enrollment | 175 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2030-05-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 175 participants in total. It began in 2025-12-17 with a primary completion date of 2030-05-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT07194070 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hemolytic Disease of the Fetus and Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07194070 currently recruiting?
Yes, NCT07194070 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07194070 trial being conducted?
This trial is being conducted at Indianapolis, United States, Cincinnati, United States, Portland, United States, Houston, United States and 10 additional locations.
Who is sponsoring the NCT07194070 clinical trial?
NCT07194070 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 175 participants.