Table 1

Study inclusion criteria

  1. Severe hemophilia A (VIII < 0.01 IU/mL)

  2. Peak historical inhibitor ≥ 5 BU/mL and ≤ 200 BU/mL

  3. Starting titer ≤ 10 BU/mL before randomization

  4. Titer declines to < 10 BU in < 12 mo (< 24 mo from 2006)

  5. Age < 8 years at time of randomization

  6. Local and/or central review board approval

  7. Written informed consent

  8. Ability and willingness of subject to comply with the protocol

 

  1. Severe hemophilia A (VIII < 0.01 IU/mL)

  2. Peak historical inhibitor ≥ 5 BU/mL and ≤ 200 BU/mL

  3. Starting titer ≤ 10 BU/mL before randomization

  4. Titer declines to < 10 BU in < 12 mo (< 24 mo from 2006)

  5. Age < 8 years at time of randomization

  6. Local and/or central review board approval

  7. Written informed consent

  8. Ability and willingness of subject to comply with the protocol

 
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