Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FEIBA · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Number of participants with AEs particular to allergic-type hypersensitivity reactions were assessed. Clinical manifestations of hypersensitivity reactions included, but was not limited to skin rash, pruritus (itching), urticaria (hives), angioedema (for example, swelling of the lips and/or tongue) and anaphylactic reaction.
Participants with adverse events related to thromboembolic event were reported. Clinical manifestations of thromboembolic events included, but was not limited to myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke and transitory ischemic attack.
Infusion sites were monitored for pain, tenderness, erythema, and swelling. Infusion site evaluations were made by clinical staff or by the participant or caregiver.
Number of participants with vital signs considered as AEs were assessed. Vital signs included body temperature (degree Celsius or degrees Fahrenheit \[°C or °F\]), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (millimeter of mercury \[mmHg\]).
Number of participants with Laboratory Assessments considered as AEs were assessed. Laboratory assessments included hematology, clinical chemistry, coagulation testing, serological testing, pregnancy testing, cluster differentiation 4 (CD4).
| Arm | Type | Description |
|---|---|---|
| Part 1:FEIBA 85±15 U/kg at Regular Volume Then 50% Reduced Volume at 2 U/kg/min Rate or Vice Versa | EXPERIMENTAL | Participants who were eligible were randomized to receive: 3 infusions (infusions 1, 2 and 3) of factor eight inhibitor bypassing activity (FEIBA) 85 ± 15 U/kg, reconstituted in regular volume sterile water for injection (SWFI) followed by 3 infusions (infusions 4, 5 and 6) of FEIBA 85 ± 15 U/kg reconstituted in 50% reduced volume SWFI (Sequence A) or: 3 infusions (infusions 1, 2 and 3) of FEIBA 85 ± 15 U/kg, reconstituted in 50% reduced volume SWFI, followed by 3 infusions of FEIBA 85 ± 15 U/kg, reconstituted in regular volume SWFI (Sequence B). All infusions in Part 1 were given at the standard infusion rate of 2 U/kg/min. |
| Part 2:FEIBA 85±15U/kg 50% Reduced Volume at 4U/kg/min Rate Then at 10U/kg/min Rate | EXPERIMENTAL | Participants who completed Part 1, received FEIBA 85 ± 15 U/kg, reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min for infusions 7, 8, and 9, followed by FEIBA 85 ± 15 U/kg, reconstituted in 50% reduced volume SWFI at an increased rate of 10 U/kg/min for infusions 10, 11, and 12. |
| Name | Type | Description |
|---|---|---|
| FEIBA | BIOLOGICAL | Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate \[APCC\]), FEIBA NF. |
Inclusion Criteria: 1. Greater than or equal to (\> or =) 18 to less than or equal to (\< or =) 65 years old at the time of screening. 2. Hemophilia A or B of any severity, with a documented \> or = 3 months history of inhibitors (\> or = 0.6 Bethesda units \[BU\]) requiring the use of bypassing ag...
FEIBA is used for the treatment of Hemophilia A or B with inhibitors. It is an anti-inhibitor coagulant complex that is being studied in a Phase 3 clinical trial for this indication. The drug is intended to help manage bleeding episodes in patients who have developed inhibitors to standard clotting factor replacement therapy.
FEIBA is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the pharmaceutical company responsible for the research and development of this drug for the treatment of Hemophilia A or B with inhibitors.
FEIBA is in Phase 3 clinical development. It has completed one Phase 3 trial, and the drug is still being investigated for its use in Hemophilia A or B with inhibitors. As an investigational drug, it has not yet been approved for commercial use.
FEIBA has been studied in a Phase 3 clinical trial with the identifier NCT02764489, titled "FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)". This trial enrolled 45 participants with Hemophilia A or B with inhibitors and was conducted in Croatia, North Macedonia, and Ukraine.
FEIBA is a distinct anti-inhibitor coagulant complex developed by Takeda. It is specifically designed for patients with Hemophilia A or B who have inhibitors. While it serves a similar purpose to other bypassing agents, FEIBA has its own unique formulation and is being studied in its own clinical trials.