The largest clinical trial program in hemophilia A 1-3,9

HEMLIBRA® was studied in adult, adolescent, and pediatric hemophilia A patients with and without factor VIII inhibitors.

Trial design
A randomized, multicenter, open-label, clinical trial


Patient population

  • 152 adult and adolescent males (aged ≥12 years and ≥40 kg)
  • With hemophilia A without FVIII inhibitors
  • Randomized comparison: 89 patients previously treated with on-demand FVIII
  • Intra-patient comparison: 63 patients previously treated with prophylactic FVIII

Maintenance doses

  • Randomized comparison: HEMLIBRA 1.5 mg/kg QW, HEMLIBRA 3 mg/kg Q2W, or no prophylaxis
  • Intra-patient comparison: HEMLIBRA 1.5 mg/kg QW

Trial design
A randomized, multicenter, open-label, clinical trial 


Patient population

  • 109 adult and adolescent males (aged ≥12 years and ≥40 kg)
  • With hemophilia A with FVIII inhibitors
  • Previously received either on-demand or prophylactic treatment with BPAs

Maintenance doses

  • HEMLIBRA 1.5 mg/kg QW or no prophylaxis

Trial design
A non-randomized, multicenter, open-label, clinical trial 


Patient population

  • 68 pediatric males aged <12 years (or 12–17 years and <40 kg)
  • With hemophilia A with FVIII inhibitors

Maintenance doses

  • HEMLIBRA 1.5 mg/kg QW, HEMLIBRA 3 mg/kg Q2W, or HEMLIBRA 6 mg/kg Q4W

Aim for zero treated bleeds 1

The majority of patients receiving HEMLIBRA had zero bleeds requiring treatment, regardless of age or FVIII inhibitor status.

See more data for pediatric patients.

CI=confidence interval; FVIII=factor VIII; QW=once weekly; Q2W=once every 2 weeks; Q4W=once every 4 weeks.

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