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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2025

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At a glance

Most Recent Events

  • 10 Jul 2025 Planned End Date changed from 4 Oct 2028 to 2 Apr 2032.
  • 13 Jan 2025 Planned End Date changed from 1 Oct 2028 to 4 Oct 2028.
  • 13 Jan 2025 Planned primary completion date changed from 1 Oct 2028 to 4 Oct 2028.

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