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Clinical Trials in Denmark / NCT06008938
Recruiting Observational

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

NCT06008938 · tracked via the Priya Life Science Denmark tracker
Sponsor
CSL Behring
Phase
Observational
Started
2023-06-15
Last updated
2026-02-19

Condition(s) studied

Hemophilia B

Investigational drug(s) / intervention(s)

HEMGENIXFactor IX (FIX)

HEMGENIX: HEMGENIX is a gene therapy medicinal product that aims to deliver a factor IX (FIX) gene expression cassette to the liver of patients with hemophilia B.

Factor IX (FIX): FIX prophylaxis therapy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
American Thrombosis and Hemostasis Network Rochester New York Recruiting
Medical University Vienna Vienna Austria Recruiting
Aarhus Universitetshospital Århus N Denmark Recruiting
Centre Hospitalier Universitaire de Brest / CHU Morvan Brest France Recruiting
Centre Régional de Traitement de l'Hémophilie Nantes France Recruiting
CHU Nancy - Hôpital Brabois Vandœuvre-lès-Nancy France Recruiting
Klinik für Angiologie/ Hämostaseologie Berlin Germany Recruiting
University of Clinic Bonn Bonn Germany Recruiting
Klinikum der Johann-Wolfgang Goethe Universitaet Frankfurt Germany Recruiting
Hannover Medical School Hanover Germany Recruiting
Hospital Alvaro Cunqueiro Dr. Manuel Rodriquez-Lopez Vigo Spain Recruiting
University Hospital Bern Inselspital Bern Switzerland Recruiting

More CSL Behring trials in Denmark

Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis Recruiting
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD) Recruiting
Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies Recruiting
Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222) Enrolling by invitation

Other trials for the same condition

A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B Recruiting
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors Recruiting
Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06008938 on ClinicalTrials.gov ↗ ← All trials in Denmark