Recruiting

Anemia Risk

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07194070

Conditions

Hemolytic Disease of the Fetus and Newborn

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Study Details

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.

Conditions

Hemolytic Disease of the Fetus and Newborn

Study ID

NCT07194070

Start date

Dec 17, 2025

Status verified date

Aug, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

May 26, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

175 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

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.

Primary outcome measure

  • Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period [ Time Frame: From conception through 4 weeks of age or 41 weeks PMA, whichever is later ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.