SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04563520
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hemophilia A

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Emicizumab — DRUG
    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.
  • FEIBA — DRUG
    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.
  • rFVIIa — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental treatment
    Participants will have a first/baseline thrombin generation assay (TGA) sample (to be processed within 60 minutes), followed by an infusion at 15 U/kg dose of aPCC, and provide a second TGA sample 15-30 minutes after to be processed within 60 minutes. If required, a subsequent TGA sample will be obtained upon a 25 U/kg dose of aPCC to be processed within 60-90 minutes.

Primary Outcome Measure

Thrombin generation capacity after aPCC (FEIBA) infusion [ Time Frame: Baseline and up to 30 minutes after infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30322
Robert Sidonio, MD
[email protected]
4047851637
Emory University HospitalAtlantaGeorgia30322-

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By research site
Children's Healthcare of Atlanta· Atlanta, GAEmory University Hospital· Atlanta, GA

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