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

ConditionHemophilia B
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCSL Behring

About this trial

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.

Eligibility criteria

Qualifiers

- 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.

- 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.

Disqualifiers

- The patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.

Trial design

Treatments tested in this trial

  • HEMGENIX
  • Factor IX (FIX)

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators