Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02764489 | FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR) | PHASE3 | COMPLETED | 45 | — | — | Feb 12, 2019 | Dec 27, 2021 | Feb 14, 2023 | 3 | Croatia, North Macedonia +1 |
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...