NCT06008938Recruiting
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
An Observational Post-authorization Long-term Follow-up Study to Characterize the Effectiveness and Safety of HEMGENIX® (Etranacogene Dezaparvovec) in Patients With Hemophilia B
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 15 Aug 2023
- Start date
- 15 Jun 2023
- Primary completion date
- 1 Aug 2043
- Lead sponsor
- CSL Behring
- Diseases
- Haemophilia
- NCT number
- NCT06008938
What you commit to
- Study type: Observational
- Planned participants: 500
- From 15 Jun 2023 to the primary completion date, 1 Aug 2043
- 12 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- The patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.
Other
- HEMGENIX Cohort:
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| University Hospital Bern / Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Klinik für Angiologie/ Hämostaseologie Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| University of Clinic Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Klinikum der Johann Wolfgang Goethe-Universitaet Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Århus N | Denmark | Recruiting |
| Hospital Alvaro Cunqueiro Dr. Manuel Rodriquez-Lopez Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Centre Hospitalier Universitaire de Brest / CHU Morvan Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Régional de Traitement de l'Hémophilie Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| CHU Nancy - Hôpital Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| American Thrombosis and Hemostasis Network Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.