Status:
COMPLETED
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
Lead Sponsor:
Tulane University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Hemophilia A
Eligibility:
MALE
12-120 years
Phase:
EARLY_PHASE1
Brief Summary
This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive ...
Detailed Description
The study aims to determine the hemostatic effect of different Factor IX (FIX) concentrates when added to the plasma of patients on emicizumab prophylaxis and compare it to the hemostatic effect obtai...
Eligibility Criteria
Inclusion
- Signed Informed Consent/Assent Form
- Male patients, Age 12 years and older at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Diagnosis of severe hemophilia A and are receiving emicizumab prophylaxis, on a weekly maintenance regimen
Exclusion
- Not able to sign consent
- Not willing to provide extra blood for the experiments.
- Patients carrying the diagnoses of other coagulopathies in addition to hemophilia A
- Patients that have received any hemostatic agent within 5 half-lives of the blood draw. This applies to any agent that might have been used for any reason prior to the blood draw and might affect the global hemostasis.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05281718
Start Date
August 1 2022
End Date
July 14 2024
Last Update
January 20 2025
Active Locations (2)
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1
Tulane University Lakeside Hospital and Clinics
Metairie, Louisiana, United States, 70001
2
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112