SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
ConditionHemophilia A
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6+
SponsorEmory University
About this trial
The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis.
Eligibility criteria
Qualifiers
Moderately severe hemophilia A, defined as FVIII level <0.05 IU/mL before development of an inhibitor
Age ≥6 years of age at time of informed consent
Documented on 2 occasions a high titer inhibitor (>5 BU/mL) with a 72-hour washout within 2 years of enrollment
Parent/guardian (Legally Authorized Representative) or the patient has provided written informed consent
Disqualifiers
Inherited or acquired bleeding disorder other than hemophilia A excluding low VWF (>30% VWF:RCo or VWF:GP1bm)
Had an active bleed requiring factor therapy at screening
Previous or current treatment for thromboembolic disease or signs of thromboembolic disease (excluding previously resolved line-associated thrombosis)
Had a surgical procedure 14 days before screening
Trial design
Treatments tested in this trial
- Emicizumab
- FEIBA
- rFVIIa
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Emory University
Lead sponsor
Takeda Pharmaceuticals North America, Inc.
Collaborator
Source ClinicalTrials.gov