Status:
RECRUITING
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
Lead Sponsor:
CSL Behring
Conditions:
Hemophilia B
Eligibility:
All Genders
18+ years
Brief Summary
This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in patients with hemophilia B. The study will also in...
Eligibility Criteria
Inclusion
- HEMGENIX Cohort:
- \- Treatment with commercial HEMGENIX.
- \- Have provided signed written informed consent within 3 months before or within 6 months after HEMGENIX treatment, or within 6 months of when the study is initiated at the participating site.
- FIX Prophylaxis Cohort:
- \- Adult patients (≥ 18 years) with hemophilia B who have consented and enrolled in ATHN Transcends Hemophilia Cohort (or a similar registry) and are receiving FIX prophylaxis therapy.
Exclusion
- HEMGENIX Cohort:
- \- The patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.
Key Trial Info
Start Date :
June 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2043
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06008938
Start Date
June 15 2023
End Date
August 1 2043
Last Update
December 26 2025
Active Locations (10)
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1
American Thrombosis and Hemostasis Network
Rochester, New York, United States, 14604
2
Medical University Vienna
Vienna, Austria
3
Aarhus Universitetshospital
Århus N, Denmark
4
Centre Hospitalier Universitaire de Brest / CHU Morvan
Brest, France