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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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• HEMGENIX (genetic)
• Factor IX (FIX) (biological)

Sponsor: CSL Behring · Participants: 500 · Started: Jun 15, 2023

Contact the study team

• Trial Registration Coordinator · Phone: +1 610-878-4697

Official record on ClinicalTrials.gov — NCT06008938

Locations in the U.S.

Conditions

• Hemophilia B

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.