Clinical Trial

Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B

Study acronym: IX-TEND 3004
Recruiting Phase 3
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Summary
This is a phase 3, prospective, open-label, single-arm, single-dose, multicenter study investigating the efficacy, safety, and tolerability of CSL222 (AAV5-hFIXco-Padua) in adolescent male participants with severe or moderately severe hemophilia B.
Protocol Amendment History 2 changes
notable Trial sites expanded: 2 -> 12 locations 2026-07-21
notable Trial sites reduced: 11 -> 2 locations 2026-05-28
Trial Details
NCT Number NCT07080905
Lead Sponsor CSL Behring
Conditions Hemophilia B
Enrollment 20 participants
Start Date 2025-07-28
Primary Completion 2033-10-24 (estimated)
Study Completion 2033-10-24 (estimated)
Updated on ClinicalTrials.gov 2026-08-05