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Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)

Study acronym: IX-TEND 3003
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites revised (28)v27 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv26
  3. Study sites: 27 to 28v25
  4. Study sites: 21 to 27v24
  5. Study sites: 20 to 21v23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 13 to 20v22
  2. Study sites: 12 to 13v21
  3. Study sites: 11 to 12v20
  4. Study sites: 8 to 11v19
  5. Study sites: 6 to 8v18
  6. Study sites: 5 to 6 Primary and study completion dates: Mar 2035 to Mar 23, 2035 · Eligibility criteria expanded, about 8 words · Secondary endpoints: 12 to 16v17 Show 3 more changesShow less
    • Primary and study completion dates: Mar 2035 to Mar 23, 2035
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 12 to 16

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 4 to 5v16
  8. 5 versions Re-verified since Feb 26, 2024, no change to tracked fieldsv11-v15
  9. Study sites: 3 to 4v10
  10. Study sites: 2 to 3v9
  11. Study sites: 1 to 2v8
  12. 2 versions Re-verified since Oct 30, 2023, no change to tracked fieldsv6-v7
  13. Start date: Aug 25, 2023 to Aug 30, 2023 Secondary endpoints: 10 to 12v5 Show 1 more changeShow less
    • Secondary endpoints: 10 to 12

    See this version in full on ClinicalTrials.gov ↗

  14. Re-verified, no change to tracked fieldsv4
  15. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1 · Start date changed from estimate of Aug 2023 to Aug 25, 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2023 to Aug 25, 2023
  16. Study Status, Eligibilityv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CSL Behring
30 trials monitored
See 2 trials at risk
Hemophilia
236 trials monitored
See 12 trials at risk
The primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia B who were treated with CSL222 (CSL222) in parent studies CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).
Trial Details
NCT Number NCT05962398
Lead Sponsor CSL Behring
Conditions Hemophilia B
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov