Actively Recruiting
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
Led by CSL Behring · Updated on 2026-02-19
500
Participants Needed
12
Research Sites
1050 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Treatment with commercial HEMGENIX for the HEMGENIX cohort
- Signed written informed consent within 3 months before or within 6 months after HEMGENIX treatment, or within 6 months of study start at participating site
- Adult patients (18 years or older) with hemophilia B receiving FIX prophylaxis therapy and enrolled in ATHN Transcends Hemophilia Cohort or similar registry for the FIX prophylaxis cohort
You will not qualify if you...
- Patients treated with etranacogene dezaparvovec in a clinical trial for the HEMGENIX cohort
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
American Thrombosis and Hemostasis Network
Rochester, New York, United States, 14604
Actively Recruiting
2
Medical University Vienna
Vienna, Austria
Actively Recruiting
3
Aarhus Universitetshospital
Århus N, Denmark
Actively Recruiting
4
Centre Hospitalier Universitaire de Brest / CHU Morvan
Brest, France
Actively Recruiting
5
Centre Régional de Traitement de l'Hémophilie
Nantes, France
Actively Recruiting
6
CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, France
Actively Recruiting
7
Klinik für Angiologie/ Hämostaseologie
Berlin, Germany
Actively Recruiting
8
University of Clinic Bonn
Bonn, Germany
Actively Recruiting
9
Klinikum der Johann-Wolfgang Goethe Universitaet
Frankfurt, Germany
Actively Recruiting
10
Hannover Medical School
Hanover, Germany
Actively Recruiting
11
Hospital Alvaro Cunqueiro Dr. Manuel Rodriquez-Lopez
Vigo, Spain
Actively Recruiting
12
University Hospital Bern Inselspital
Bern, Switzerland
Actively Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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