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Factor VIII Inhibitor Bypassing Activity · 1 trial · 3 indications
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
| Arm | Type | Description |
|---|---|---|
| Prophylaxis arm | EXPERIMENTAL | - |
| On-demand arm | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) | BIOLOGICAL | 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period |
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...
Factor VIII Inhibitor Bypassing Activity is used to treat bleeding in people with hemophilia A or B who have developed inhibitors, which are antibodies that block standard factor replacement. It is given as a bypassing agent for both on-demand bleeding control and prophylactic treatment in this patient population.
Factor VIII Inhibitor Bypassing Activity targets coagulation factor X, also known as F10. By acting at this point in the clotting cascade, it bypasses the need for factor VIII or factor IX, which are inhibited in patients with high-titer inhibitors, and supports clot formation.
Factor VIII Inhibitor Bypassing Activity is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company responsible for the product.
Factor VIII Inhibitor Bypassing Activity is in Phase 3 clinical development. It is an investigational agent and has been studied in a completed Phase 3 trial, but it is not described as approved.
Factor VIII Inhibitor Bypassing Activity has been studied in one Phase 3 trial, NCT00851721, titled 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. The trial is completed and enrolled 52 participants.