hemolytic disease of the fetus and newborn blood group incompatibility
Conditions
Interventions
The study population will be the population recruited to the Janssen-sponsored Phase 3 EBF3001 clinical trial i.e. (1) pregnant women with an obstetrical history of HDFN-related fetal anemia with IUT,
Sponsors
BillionToOne Inc.
Eligibility
Inclusion criteria
Inclusion criteria: Female, of legal age to consent, at least 10 weeks of gestational age not conceived with donor egg or a gestational carrier being used.Subject completed an informed consent form.Specimen is received within 14 days of collection date.Specimen is whole blood collected in a Streck, cell-free DNA tube.Specimen is received with sufficient volume (>5mL) and complete study subject information.The specimen was received in good condition and was accepted for testing in accordance with established procedures. (The inclusion criteria for enrollment onto the Janssen-sponsored Phase 3 clinical trial are detailed within Section 5 of the EBF3001 clinical trial protocol, EU CT number 2022-502629-16-00, which is included in the CTA application to all Member States concerned).
Exclusion criteria
Exclusion criteria: Specimen collected from a participant not of legal age to consent.Specimen collected from a participant <10 weeks of gestational age.The specimen was collected from a participant who did not sign the informed consent.Specimen is received completely unlabeled or with mismatched study subject identifiers.Specimen or packaging is received damaged (cracked, broken, or spilled), visibly contaminated, or indicating that it contains radioactive material.Incorrect specimen is collected, or specimen collected in wrong tube type (not whole blood, or whole blood collected in a tube that is not a Streck, cell-free DNA tube).Blood Tube Expiration date is earlier than the collection date.Sample is received after 14 days from collection date.There is visible contamination of the blood samples.Blood volume is not sufficient (<5mL) for sample processing. (The exclusion criteria for enrollment onto the Janssen-sponsored Phase 3 clinical trial is detailed within Section 5 of the EBF3001 clinical trial protocol, EU CT number 2022-502629-16-00, which is included in the CTA application to all Member States concerned).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical trial assay (CTA) will be used to screen maternal blood samples for fetal red blood cell antigens RhD, RhC, Rhc, RhE, or Kell from alloimmunized women as one of the eligibility criteria to determine enrollment in the Janssen-Cilag International N.V. sponsored Phase 3 clinical study Protocol 80202135EBF3001. The primary objective of the BillionToOne Inc. sponsored performance study will be to determine the assay call rate against pre-specified acceptance criteria, for all subjects tested for the Janssen study. The call rate assesses the assay’s ability to successfully identify the presence or absence of fetal antigen in the maternal sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| None | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactBryce Moller
BillionToOne
Outcome results
None listed