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Factor VIII Inhibitor Bypassing Activity

Phase 3

Hemophilia A or B With Inhibitors | Monoclonal antibody | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: May 19, 2021

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Factor VIII Inhibitor Bypassing Activity · 1 trial · 3 indications

Phase 3 1
NCT00851721Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer InhibitorHemophilia A or B With Inhibitors
COMPLETED52 Analytics
PHASE3COMPLETED
Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
Hemophilia A or B With Inhibitors
NCT0085172152
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Study Endpoints

Primary Endpoints

Reduction in Annualized Bleeding Episode Rate (ABR) Among Participants Receiving Prophylactic Treatment as Compared to Those Treated On-demand
12 months ± 14 days

Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens: 1.On-Demand: FEIBA NF dose \& dosing interval as prescribed by treating physician 2.Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period Annualized rate of bleeding episodes was calculated as: (Number of bleeding episodes/observed treatment period in days) \* 365.25

Secondary Endpoints

Annualized Bleeding Rate by Treatment Regimen, Bleeding Etiology, and Bleed Type
12 months ± 14 days
Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens by Bleeding Etiology, and Bleeding Type
12 months ± 14 days
Annualized Bleeding Rate for New Target Joints
12 months ± 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Prophylaxis armEXPERIMENTAL -
On-demand armACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)BIOLOGICAL85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
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Eligibility Criteria

Age Range4 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Signed and dated informed consent form by the participant or the participant's legally authorized representative * The participant is ≥ 4 to ≤ 65 years of age * The participant has a Karnofsky performance score of ≥ 60 * Hemophilia A and B of any severity, with documented hist...

Countries:United StatesBrazilBulgariaCroatiaJapanNew ZealandPolandRomaniaRussiaUkraine
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