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An Extension Study Assessing the Long-term Safety and Efficacy of Etranacogene Dezaparvovec (CSL222) Previously Administered to Adult Male Subjects With Hemophilia B

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Trial Profile

An Extension Study Assessing the Long-term Safety and Efficacy of Etranacogene Dezaparvovec (CSL222) Previously Administered to Adult Male Subjects With Hemophilia B

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 08 Jun 2026

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At a glance

  • Drugs Etranacogene dezaparvovec (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions
  • Acronyms IX-TEND 3003
  • Sponsors CSL Behring

Most Recent Events

  • 20 May 2026 According to a CSL Behring media release, the five-year data mark the final analysis for the HOPE-B study, but participants who consent will continue to be monitored in the IX-TEND 222-3003 extended follow-up study (NCT05962398), which will track patients for up to 15 years post-treatment.
  • 19 Sep 2024 Planned End Date changed from 1 Mar 2035 to 23 Mar 2035.
  • 19 Sep 2024 Planned primary completion date changed from 1 Mar 2035 to 23 Mar 2035.

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