NCT06008938Recruiting
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
CSL Behring
Start Date
6/15/2023
Completion Date
8/1/2043
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 include a cohort of patients with hemophilia B treated with FIX prophylaxis to enable interpretation of relevant efficacy and safety findings of HEMGENIX.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* HEMGENIX Cohort:
* \- The patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.
Interventions
GENETIC
HEMGENIX
BIOLOGICAL
Factor IX (FIX)
Conditions
Hemophilia B
Locations
American Thrombosis and Hemostasis Network
Rochester, New York 14604
United States
Medical University Vienna
Vienna,
Austria
Aarhus Universitetshospital
Århus N,
Denmark
Centre Hospitalier Universitaire de Brest / CHU Morvan
Brest,
France
Centre Régional de Traitement de l'Hémophilie
Nantes,
France
CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy,
France
Klinik für Angiologie/ Hämostaseologie
Berlin,
Germany
University of Clinic Bonn
Bonn,
Germany
Klinikum der Johann-Wolfgang Goethe Universitaet
Frankfurt,
Germany
Hannover Medical School
Hanover,
Germany
Hospital Alvaro Cunqueiro Dr. Manuel Rodriquez-Lopez
Vigo,
Spain
University Hospital Bern Inselspital
Bern,
Switzerland