Gene Transfer, Dose-Finding Safety, Tolerability, and Efficacy Study of SPK-8011 [a Recombinant Adeno-Associated Viral Vector With Human Factor VIII Gene] in Individuals With Hemophilia A

Trial Profile

Gene Transfer, Dose-Finding Safety, Tolerability, and Efficacy Study of SPK-8011 [a Recombinant Adeno-Associated Viral Vector With Human Factor VIII Gene] in Individuals With Hemophilia A

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Oct 2017

At a glance

  • Drugs SPK 8011 (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Pharmacogenomic; Therapeutic Use
  • Sponsors Spark Therapeutics
  • Most Recent Events

    • 02 Aug 2017 According to a Spark Therapeutics media release, based on the preliminary results the company elected to double the dose and recently infused a third participant at a dose of 1 x 1012 vector genomes (vg)/kg body weight.
    • 02 Aug 2017 Preliminary results from the study published in the Spark Therapeutics Second Quarter 2017 Financial Results.
    • 21 Dec 2016 Status changed from planning to recruiting.
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