Hemophilia B

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

NCT06008938 | PHASE 3 | OBSERVATIONAL

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.

1 Sites

500 Participants

Recruiting

18 Years to 65 Years

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SUBMIT

American Thrombosis and Hemostasis Network

Rochester,New York,United States,14604

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov