This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From date of first dose to Week 52/End of Study (EOS) Visit
Number of Participants Who Received Corticosteroids for Presumed Immune Response
Timeframe: Up to Week 52/EOS Visit
Peak Factor VIII (FVIII) Activity Levels Assessed by One-Stage Coagulation Assay (OSA)
Timeframe: Up to Week 52/EOS visit
Nominal FVIII Level by OSA at Week 52/EOS
Timeframe: Up to Week 52/EOS Visit
Spontaneous Bleeds Annualized Bleeding Rate
Timeframe: Week 5 up to Week 52/EOS Visit
Total Annualized FVIII Infusion Rate
Timeframe: Week 5 up to Week 52/EOS Visit