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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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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: 26 Aug 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

    • 16 Jul 2024 According to a CSL Behring media release, company announced that the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) recommended public drug plan reimbursement for HEMGENIX (etranacogene dezaparvovec) for the treatment of eligible adults with hemophilia B, recommendation is based on results from the ongoing Phase III HOPE-B trial.
    • 04 Jul 2024 According to a CSL media release, Australia's Therapeutic Goods Administration (TGA) has granted provisional registration for HEMGENIX (etranacogene dezaparvovec) for treatment of adults with haemophilia B (congenital factor IX deficiency), without a history of factor IX inhibitors, who: currently use factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or repeated, serious spontaneous bleeding episodes.
    • 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.

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