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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

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: 13 Dec 2018

At a glance

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

    • 15 Nov 2018 According to an uniQure media release, the Data Monitoring Committee will meet before the end of the year to evaluate and potentially confirm the dose for the Phase III study. The Company expects to initiate the dosing phase of this study in the first quarter of 2019.
    • 24 Sep 2018 According to an uniQure media release, dose for the trial will be confirmed before the end of 2018.
    • 28 Jun 2018 According to the uniQure media release, Steven Pipe is the principal investigator for this trial.
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