NCT06008938

An Observational Post-authorization Long-term Follow-up Study to Characterize the Effectiveness and Safety of HEMGENIX® (Etranacogene Dezaparvovec) in Patients With Hemophilia B

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.

Want to learn more about this trial?

Request More Info

Interventions

HEMGENIXGENETIC
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)BIOLOGICAL
FIX prophylaxis therapy

Study Locations

FacilityCityStateCountry
American Thrombosis and Hemostasis NetworkRochesterNew YorkUnited States
Medical University ViennaViennaAustria
Aarhus UniversitetshospitalÅrhus NDenmark
Centre Hospitalier Universitaire de Brest / CHU MorvanBrestFrance
Centre Régional de Traitement de l'HémophilieNantesFrance
CHU Nancy - Hôpital BraboisVandœuvre-lès-NancyFrance
Klinik für Angiologie/ HämostaseologieBerlinGermany
University of Clinic BonnBonnGermany
Klinikum der Johann-Wolfgang Goethe UniversitaetFrankfurtGermany
Hannover Medical SchoolHanoverGermany
Hospital Alvaro Cunqueiro Dr. Manuel Rodriquez-LopezVigoSpain
University Hospital Bern InselspitalBernSwitzerland

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026