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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 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.

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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.

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

FieldValue
Enrollment Target 5 participants
Start Date 2026-03
Est. Completion 2027-03
Phase Phase 3

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT04563520

The ClinicalTrials.gov registry entry for NCT04563520 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (95% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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