HAVEN 1

HAVEN 1 studied 109 adults and adolescent males with hemophilia A (12 to 75 years and weighing more than 40 kg) with factor VIII inhibitors for 24 weeks. There were three treatment groups used to evaluate how well HEMLIBRA reduced treated bleeds. There were 35 participants in Group A, 18 participants in Group B, and 49 participants in Group C.

The results showed:

  • Patients experienced a statistically significant reduction for the following endpoints compared with no prophylaxis
    • Bleed rates for all bleeds
    • Treated spontaneous bleeds 
    • Treated joint bleeds
    • Treated target joint bleeds

Statistical significance is a mathematical measure of the difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone.

Individual results may vary. Talk with your healthcare provider to determine if HEMLIBRA is right for you.

HAVEN 2 Interim

The interim efficacy analysis of the 23 children (younger than 12 years of age) with hemophilia A with factor VIII inhibitors who had been receiving once-weekly HEMLIBRA prophylaxis for at least 12 weeks showed:
 

The intra-patient analysis results are from 13 patients who participated in the Non-Interventional Study (NIS) after at least 12 weeks of treatment (prophylactic treatment for 12 patients and on-demand treatment for 1 patient).

The intra-patient analysis found that weekly HEMLIBRA prophylaxis resulted in a: 

A final analysis will be completed at the end of the trial. Individual results may vary. Talk with your healthcare provider to find out if HEMLIBRA is right for you.

To learn more about HAVEN 1 and HAVEN 2 clinical trials, click here

Clinical Trials

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