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NCT04563520 · ClinicalTrials.gov registry record · Phase 3
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
A Phase 3 study of Hemophilia A, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
- 2
- Study locations
NCT04563520: Recruiting Phase 3 study of Hemophilia A, sponsored by Emory University.
NCT04563520 is a Phase 3 study of Hemophilia A that is actively recruiting participants, run by Emory University. The registered enrollment target is 5 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04563520, a Phase 3 study of Hemophilia A, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Thrombin generation capacity from up to two escalating doses of aPCC will be measured using a thrombin generation assay at baseline and up to 30 minutes after FEIBA infusion.
Conditions Studied
Interventions
- DRUG Emicizumab
- DRUG FEIBA
- DRUG rFVIIa
Study Locations (2)
Georgia
- Children's Healthcare of Atlanta - Atlanta
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2026-03 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
What NCT04563520 shows while recruiting
NCT04563520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 3 interventions - of which Emicizumab is the first listed.
NCT04563520 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04563520 about?
NCT04563520 is a clinical study titled "SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis". 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.
What is the current status of trial NCT04563520?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2026-03. Estimated completion is 2027-03.
What conditions does trial NCT04563520 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT04563520?
The interventions under investigation include: Emicizumab (DRUG), FEIBA (DRUG), rFVIIa (DRUG).
Who is sponsoring clinical trial NCT04563520?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04563520 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04563520's enrollment target sits among peer trials
5 39th of 42 higher than 2 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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