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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2018

At a glance

  • Drugs AMT 061 (Primary)
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms HOPE-B
  • Sponsors uniQure
  • Most Recent Events

    • 28 Jun 2018 According to the uniQure media release, Steven Pipe is the principal investigator for this trial.
    • 28 Jun 2018 According to the uniQure media release, first patient has been enrolled in this study and dosing of patients is expected to start early in the first quarter of 2019.
    • 28 Jun 2018 Status changed from planning to recruiting, according to the uniQure media release.
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