The purpose of this study is to: * 1\. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min * 2\. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume
15 JUN 2020: The temporary enrollment stop of new patients into this study due to the COVID-19 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new patients. However, some countries/sites may still have paused the enrollment of new patients due to the pandemic. 23 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate \[APCC\]), FEIBA NF.
University Hospital Center Zagreb
Zagreb, Croatia
PHI Institute for Transfusion Medicine of Macedonia
Skopje, North Macedonia
MV Sklifosovskyi Poltava Hematology
Poltava, Ukraine
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
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.
Time frame: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
Number of Participants With Any Hypersensitivity Reaction
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.
Time frame: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
Number of Participants With Any Thromboembolic Event
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.
Time frame: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
Number of Participants With Any Infusion Site Reaction
Infusion sites were monitored for pain, tenderness, erythema, and swelling. Infusion site evaluations were made by clinical staff or by the participant or caregiver.
Time frame: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
Number of Participants With AEs Leading to Study Discontinuation
Time frame: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
Number of Participants With Vital Signs Considered as AEs
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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 \[mmHg\]).
Time frame: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
Number of Participants With Laboratory Assessments Considered as AEs
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).
Time frame: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)