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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Jul 2018

At a glance

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

    • 11 Jul 2018 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Apr 2018 to 1 Jul 2018..
    • 14 Jun 2018 Planned primary completion date changed from 1 Jul 2018 to 1 Aug 2018.
    • 14 Jun 2018 Status changed from not yet recruiting to recruiting.
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