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Phase IIb, Open-label, Single-dose, Single-arm, Multi-center Trial to Confirm the Factor IX Activity Level of the 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 IIb, Open-label, Single-dose, Single-arm, Multi-center Trial to Confirm the Factor IX Activity Level of the 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

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Dec 2018

At a glance

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

    • 04 Dec 2018 Status changed from recruiting to active, no longer recruiting.
    • 15 Nov 2018 According to an uniQure media release, the company expects to submit data from the Phase IIb study to the FDA and EMA by the end of the year.
    • 15 Nov 2018 According to an uniQure media release, the company will provide clinical updates on the study at medical conferences in 2019.
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