Clinical Trial

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

Study acronym: IX-TEND 4001
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-08-23; most recent amendment 2026-02-18.
Status change: Not Yet Recruiting → Recruiting 2023-10-12
Trial Details
NCT Number NCT06008938
Lead Sponsor CSL Behring
Conditions Hemophilia B
Enrollment 500 participants
Start Date 2023-06-15
Primary Completion 2043-08-01 (estimated)
Study Completion 2043-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-19