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
Phase of Trial: Phase I/II
Latest Information Update: 02 Aug 2017
At a glance
- Drugs SPK 8011 (Primary)
- Indications Haemophilia A
- Focus Adverse reactions; Pharmacogenomic; Therapeutic Use
- Sponsors Spark Therapeutics
- 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.