At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 45 enrolled
Drug / intervention
FEIBAbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b/4, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patients With Hemophilia A or B With Inhibitors
In Brief
A Phase 3 clinical trial evaluating FEIBA for Hemophilia A or B With Inhibitors. Completed, enrolled 45 participants across 3 sites in 3 countries.
Detailed Summary
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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A or B With Inhibitors
CountriesCroatia, North Macedonia, Ukraine
CollaboratorsBaxalta Innovations GmbH, now part of Shire
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartFeb 2019
Primary CompletionDec 2021
TodayJul 2026
First PostedMay 6, 2016
Enrollment StartFeb 12, 2019
Primary CompletionDec 27, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.2 years ago
Interventions
FEIBAbiological
Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate \[APCC\]), FEIBA NF.