An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
Recruiting now
Conditions studied: Hemophilia B
In brief
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 include a cohort of patients with hemophilia B treated with FIX prophylaxis to enable interpretation of relevant efficacy and safety findings of HEMGENIX.
Key facts
- Study ID
- NCT06008938
- Run by
- CSL Behring
- People needed
- 500
- Starts
- 2023-06-15
- Expected to finish
- 2043-08-01
- Last updated by the study team
- 2026-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- HEMGENIX Cohort:
- - The patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.
Where it is running
- American Thrombosis and Hemostasis Network — Rochester, New York, United States (enrolling)
- Medical University Vienna — Vienna, Austria (enrolling)
- Aarhus Universitetshospital — Århus N, Denmark (enrolling)
- Centre Hospitalier Universitaire de Brest / CHU Morvan — Brest, France (enrolling)
- Centre Régional de Traitement de l'Hémophilie — Nantes, France (enrolling)
- CHU Nancy - Hôpital Brabois — Vandœuvre-lès-Nancy, France (enrolling)
- Klinik für Angiologie/ Hämostaseologie — Berlin, Germany (enrolling)
- University of Clinic Bonn — Bonn, Germany (enrolling)
- Klinikum der Johann-Wolfgang Goethe Universitaet — Frankfurt, Germany (enrolling)
- Hannover Medical School — Hanover, Germany (enrolling)
- Hospital Alvaro Cunqueiro Dr. Manuel Rodriquez-Lopez — Vigo, Spain (enrolling)
- University Hospital Bern Inselspital — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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