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

First listed
Sep 24, 2020
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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