Clinical Trial

Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)

Study acronym: IX-TEND 3003
Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
The primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia B who were treated with CSL222 (CSL222) in parent studies CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2023-07-18; most recent amendment 2025-07-17.
Status change: Not Yet Recruiting → Enrolling by Invitation 2023-09-07
Trial Details
NCT Number NCT05962398
Lead Sponsor CSL Behring
Conditions Hemophilia B
Enrollment 56 participants
Start Date 2023-08-30
Primary Completion 2035-03-23 (estimated)
Study Completion 2035-03-23 (estimated)
Updated on ClinicalTrials.gov 2025-07-18