SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis

PHASE3RecruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Hemophilia A
Interventions
DRUG

Emicizumab

HEMLIBRA® is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

DRUG

FEIBA

"FEIBA™ is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia patients with inhibitors for: control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.~The max dose allowed for aPCC will be 50 U/kg dose given at a single visit."

DRUG

rFVIIa

rFVIIa is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents with hemophilia with inhibitors.

Trial Locations (2)

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

RECRUITING

Emory University Hospital, Atlanta

All Listed Sponsors
collaborator

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

lead

Emory University

OTHER