A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry (GERANIUM)

Janssen (J&J Innovative Medicine)

Status: Enrolling

Conditions: Hemolytic Disease of the Fetus and Newborn

Treatments: Other: Standard of Care

Study type: Observational

Funder types: Industry

Identifiers

NCT07194070

NOPRODEBF0001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 175 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

175 participants in 1 patient group

Pregnant Participants at Risk for Hemolytic Disease of the Fetus and Newborn (HDFN)

Description:

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).

Treatment:

Other: Standard of Care