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Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B

Trial Profile

Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B

Status: Completed
Phase of Trial: Phase III/IV

Latest Information Update: 13 Mar 2024

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At a glance

  • Drugs Trenonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Sponsors Medexus Pharmaceuticals
  • Most Recent Events

    • 08 Mar 2024 According to a XOMA media release, Medexus Pharmaceuticals has submitted pediatric label expansion application for IXINITY which has been accepted for review by FDA. FDA decision expected in 2024.
    • 26 Aug 2022 Status changed from active, no longer recruiting to completed.
    • 30 Aug 2021 Planned End Date changed from 1 Sep 2021 to 30 Jul 2022.
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