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Study Designs

 

    1

    The PROTECT VIII trial was designed to reflect real-world treatment

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    Jivi prophylactic dosing was tailored to patients’ bleeding phenotypes.1,2

    Jivi prophylactic dosing

    An additional 20 patients entered a control arm of on-demand treatment1

     

    * Four patients in the prophylactic arms discontinued study treatment during the first 10 weeks (one due to an AE and three withdrew consent).1

    † Defined as joint or muscle bleeds and no identified trauma.

    ‡ Patients treated on demand during PROTECT VIII had the option to either continue on-demand treatment in the extension or switch to prophylaxis1,2

    Patients who received prophylaxis in the main study could either continue their regimen or switch regimens at the beginning or at any time during the extension; treatment adjustments were based on the clinical bleeding pattern.2

    ¶ Data cut off 31 January 2018.

    References

    Jivi vs other EHL FVIIIs in two head-to-head studies1,2*

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    Jivi vs. rFVIII-Fc head-to-head PK comparison1

    Alt tag

    * Based on head-to-head studies comparing the pharmacokinetic profiles of Jivi vs. rFVIII-Fc and Jivi vs. rurioctocog alfa pegol

    Phase 1, open-label crossover study to directly compare the AUC (primary endpoint) of two EHL therapies in patients with hemophilia A aged 18–65.1

    Jivi vs rurioctocog alfa pegol head-to-head PK comparison2

    Jivi vs. rFVIII-Fc

    The 50 IU/kg doses administered in this study were calculated based on the nominal potencies (1000 IU) as provided on the label of the vials. This differed from that of the actual potencies, being 1030 IU/vial for damoctocog alfa pegol and 1141 IU/vial for rurioctocog alfa pegol. This resulted in actual administered doses of approximately 3% and 14.1% higher than the planned 50 IU/kg doses for damoctocog alfa pegol and rurioctocog alfa pegol, respectively. In the analysis of PK parameters, the dose based on actual potency of the two products was compared.

    References