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A Phase I/II, Open-label, Uncontrolled, Single-dose, Dose-ascending, Multi-centre Trial Investigating an Adeno-associated Viral Vector Containing a Codon-optimized Human Factor IX Gene (AAV5-hFIX) Administered to Adult Patients With Severe or Moderately Severe Hemophilia B

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Trial Profile

A Phase I/II, Open-label, Uncontrolled, Single-dose, Dose-ascending, Multi-centre Trial Investigating an Adeno-associated Viral Vector Containing a Codon-optimized Human Factor IX Gene (AAV5-hFIX) Administered to Adult Patients With Severe or Moderately Severe Hemophilia B

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 24 Jan 2023

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At a glance

  • Drugs AMT 060 (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; First in man
  • Sponsors CSL Behring

Most Recent Events

  • 13 Dec 2022 Results outlining the observed durability of AMT-060 and etranacogene dezaparvovec in people with severe or moderately severe hemophilia B using data from 3 trials (NCT02396342, NCT03489291 and NCT03569891) presented at the 64th American Society of Hematology Annual Meeting and Exposition
  • 22 Apr 2021 Status changed from active, no longer recruiting to completed.
  • 08 Dec 2020 Results of efficacy and safety outcomes up to 5 years presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology

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