Clinical Trial

SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis

Study acronym: SAFE
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2020-09-21; most recent amendment 2026-04-23.
Status change: Not Yet Recruiting → Recruiting 2023-06-22
Trial Details
NCT Number NCT04563520
Lead Sponsor Emory University
Collaborators: Takeda Pharmaceuticals North America, Inc.
Conditions Hemophilia A
Enrollment 5 participants
Start Date 2026-06
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-29