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An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B

Recruitingn/aAges 18 Years - anyAllCSL Behring
NCT06008938 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • HEMGENIX
  • Factor IX (FIX)
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Where

12 sites
American Thrombosis and Hemostasis Network
Rochester, 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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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