Clinical Research Directory
Browse clinical research sites, groups, and studies.
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
Sponsor: CSL Behring
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.
Official title: An Observational Post-authorization Long-term Follow-up Study to Characterize the Effectiveness and Safety of HEMGENIX® (Etranacogene Dezaparvovec) in Patients With Hemophilia B
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-06-15
Completion Date
2043-08-01
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
HEMGENIX
HEMGENIX is a gene therapy medicinal product that aims to deliver a factor IX (FIX) gene expression cassette to the liver of patients with hemophilia B.
Factor IX (FIX)
FIX prophylaxis therapy
Locations (12)
American Thrombosis and Hemostasis Network
Rochester, New York, 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