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

NCT06008938 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-02-19

No results posted yet for this 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.

Conditions

  • Hemophilia B

Interventions

GENETIC

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.

BIOLOGICAL

Factor IX (FIX)

FIX prophylaxis therapy

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Global Program Director · CSL Behring

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2043-08-01
Completion
2043-08-01

Countries

  • United States
  • Austria
  • Denmark
  • France
  • Germany
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008938 on ClinicalTrials.gov