Last updated on December 2019

BAY81-8973 Pediatric Safety and Efficacy Trial


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hemophilia A
  • Age: - 12 Years
  • Gender: Male

Inclusion Criteria:

  • Male, aged </= 12 years
  • Severe hemophilia A defined as < 1% FVIII:C
  • PTPs (previously treated patients) > 50 Exposure days (ED) with any FVIII products
  • PUPs (previously untreated patients) no prior exposure to any FVIII products
  • MTPs (minimally treated patients) not previously having received more than 3 Exposure Days (ED) with any FVIII products
  • No current evidence or history of inhibitory antibody

Exclusion Criteria:

  • History of FVIII inhibitor formation
  • Diagnosed with other bleeding disorder
  • Platelet count < 100000 cells/L
  • Kidney or liver dysfunction
  • Known hypersensitivity to any FVIII

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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