NCT06008938 An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
| NCT ID | NCT06008938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CSL Behring |
| Condition | Hemophilia B |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-06-15 |
| Primary Completion | 2043-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-06-15 with a primary completion date of 2043-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Global Program Director
STUDY DIRECTOR
CSL Behring
Frequently Asked Questions
Who can join the NCT06008938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemophilia B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06008938 currently recruiting?
Yes, NCT06008938 is actively recruiting participants. Contact the research team at clinicaltrials@cslbehring.com for enrollment information.
Where is the NCT06008938 trial being conducted?
This trial is being conducted at Rochester, United States, Vienna, Austria, Århus N, Denmark, Brest, France and 8 additional locations.
Who is sponsoring the NCT06008938 clinical trial?
NCT06008938 is sponsored by CSL Behring. The principal investigator is Global Program Director at CSL Behring. The trial plans to enroll 500 participants.