Clinical Trial

Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)

Recruiting Phase 3
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Summary
The purpose of this study is to assess the risk of bleeding due to failure of expected pharmacological action of CSL222 in adults with severe or moderately severe hemophilia B with detectable pretreatment AAV5 Nabs.
Protocol Amendment History 1 change
notable Trial sites expanded: 27 -> 30 locations 2026-07-29
Trial Details
NCT Number NCT06003387
Lead Sponsor CSL Behring
Conditions Hemophilia B
Enrollment 35 participants
Start Date 2024-01-30
Primary Completion 2028-10-04 (estimated)
Study Completion 2032-04-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-07