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Open-label phase 3b study of HEMGENIX in adults with hemophilia B and detectable preexisting AAV5 neutralizing antibodies
MOH_2023-12-31_013076Phase 3Recruiting
- Sponsor
- CSL Behring
- Start
- Nov 2023
- Modality
- Gene Therapies, Recombinant Proteins and Enzymes
- Countries
- 1
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Overview
Phase 3, open-label, single-arm trial of etranacogene dezaparvovec in hemophilia B (HB), sponsored by CSL Behring. Primary endpoints: Association of pretreatment AAV5 neutralizing antibody titers with post-treatment bleeding risk and Establishment of stable factor IX expression. Started Nov 2023; status: recruiting.
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Drugs
etranacogene dezaparvovec
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Conditions
hemophilia B (HB)
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