clinical trial · NCT06003387
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)
CSL Behring·phase3·recruiting·n = 35
Hemophilia BCSL222 (AAV5-hFIXco-Padua)
brief 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.
started
Jan 30, 2024
primary completion
Oct 4, 2028
completion
Apr 2, 2032
last updated
Mar 17, 2026
official title
Phase 3b, Open-label, Multicenter, Single-dose Study Investigating Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy Administered to Adult Subjects With Severe or Moderately Severe Hemophilia B With Detectable Pretreatment AAV5 Neutralizing Antibodies
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol