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Phase IIb, Open-label, Single-dose, Single-arm, Multi-center Trial to Confirm the Factor IX Activity Level of the Serotype 5 Adeno-associated Viral Vector Containing the Padua Variant of a Codon-optimized Human Factor IX Gene (AAV5-hFIXco-Padua, AMT-061) Administered to Adult Subjects With Severe or Moderately Severe Hemophilia B

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Trial Profile

Phase IIb, Open-label, Single-dose, Single-arm, Multi-center Trial to Confirm the Factor IX Activity Level of the Serotype 5 Adeno-associated Viral Vector Containing the Padua Variant of a Codon-optimized Human Factor IX Gene (AAV5-hFIXco-Padua, AMT-061) Administered to Adult Subjects With Severe or Moderately Severe Hemophilia B

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Jan 2024

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At a glance

  • Drugs Etranacogene dezaparvovec (Primary)
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Sponsors CSL Behring

    • Most Recent Events

    • 12 Dec 2023 Results of ad hoc analysis evaluating the efficacy and safety of etranacogene dezaparvovec (data from trials NCT03489291 and NCT03569891),presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 12 Dec 2023 Results (N=35 ) assessing subset of participants with a history of chronic HCV and/or HBV presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 09 Oct 2023 Status changed from active, no longer recruiting to completed.
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