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

Aim for zero treated bleeds

The majority of hemophilia A patients receiving HEMLIBRA had zero bleeds* requiring treatment.

*Defined as bleeds treated with bypassing agents based on an adaptation of standard criteria defined by the International Society on Thrombosis and Haemostasis (ISTH). 11

"In the first 5 months since I started using HEMLIBRA, I have not treated a single bleed. HEMLIBRA is working for me."

—Matt P., California

Long-term descriptive analysis in adults and adolescents with FVIII inhibitors 3,10

n=number of patients who contributed data for analyses at each time interval.

Benefit conclusions about the bleed rates over time with HEMLIBRA cannot be drawn

  • The 95% CIs overlap in each group
  • The sample size for weeks 73-96 is also smaller, which limits interpretation of a definitive improvement

Patients reported improvement in painful swellings and mobility 3

HAVEN 1 prespecified endpoint: Haem-A-QoL physical health score at 25 weeks

Patients aged 18 and up. 1
ABR=annualized bleed rate. ABR calculated with a negative binomial regression model, which accounts for different follow-up times. 11
BPAs=bypassing agents; CI=confidence interval; FVIII=factor VIII; Haem-A-QoL=Haemophilia Quality of Life Questionnaire for Adults; QW=once weekly.

Pediatric Patients

Using HEMLIBRA in your pediatric patients with or without inhibitors