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Phase III, Open-label, Single-dose, Multi-center, Multinational Trial Investigating a 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 III, Open-label, Single-dose, Multi-center, Multinational Trial Investigating a 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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Apr 2024

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At a glance

  • Drugs Etranacogene dezaparvovec (Primary)
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms HOPE-B
  • Sponsors CSL Behring; uniQure
  • Most Recent Events

    • 15 Jan 2024 According to a CSL media release, based on results from this ongoing Phase III HOPE-B trial, Swissmedic has authorised HEMGENIX (etranacogene dezaparvovec; first and currently only gene therapy for the treatment of male adults aged >18 years with severe or moderately severe hemophilia B) in Switzerland.
    • 01 Jan 2024 Results from HOPE-B, PROLONG-9FP, B-LONG and Paradigm 2, published in the Haemophilia
    • 12 Dec 2023 Results reporting long-term efficacy and safety data over a period of 3-years of post-treatment presented at the 65th American Society of Hematology Annual Meeting and Exposition
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