Utilisation du test clinique de dépistage prénatal non invasif (NIPT) de l'antigène fœtal pour déterminer le statut de l'antigène des globules rouges fœtaux dans le cadre de l'essai clinique de phase 3 IMP parrainé par Janssen.

Résumé de l'essai

The Fetal Antigen NIPT CTA is a next-generation sequencing test intended for the qualitative detection of cell-free fetal DNA encoding for fetal antigens RhD, RhC, Rhc, RhE, or Kell in the blood of pregnant adults who are alloimmunized against the corresponding fetal red blood cell antigen and whose pregnancies are at risk of HDFN. The Fetal Antigen NIPT CTA is intended for use at ten (10) weeks or more gestational age. In addition to other enrollment criteria, such as maternal obstetric history and maternal allo-immunization status, the Fetal Antigen NIPT Test will be used to determine the potential eligibility of participants for enrollment into the Janssen clinical study EBF3001, a Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe HDFN. The Janssen EBF3001 study intends to enroll approximately 120 alloimmunized pregnant participants with an obstetrical history of HDFN-related fetal anemia with intrauterine transfusion (IUT), hydrops fetalis, fetal loss, or neonatal death in a previous pregnancy who are currently pregnant with an antigen-positive fetus who are not receiving and have no plans to receive IVIg/plasmapheresis.

Objectif principal

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.

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