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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)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 31 to 32v36
  2. Study sites: 30 to 31v35
  3. Trial sites expanded: 27 → 30 locations Eligibility criteria shortened, about 15 wordsv34 Show 1 more changeShow less
    • Eligibility criteria shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 26 to 27 Eligibility criteria expanded, about 10 wordsv33 Show 1 more changeShow less
    • Eligibility criteria expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 25 to 26 Eligibility criteria shortened, about 18 wordsv32 Show 1 more changeShow less
    • Eligibility criteria shortened, about 18 words

    See this version in full on ClinicalTrials.gov ↗

Show 30 earlier versionsHide 30 earlier versions
  1. Study sites: 23 to 25 Eligibility criteria expanded, about 20 wordsv31 Show 1 more changeShow less
    • Eligibility criteria expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 22 to 23v30
  3. Study sites: 20 to 22v29
  4. Study sites: 19 to 20v28
  5. Re-verified, no change to tracked fieldsv27
  6. Study sites: 18 to 19v26
  7. Completion date: Oct 4, 2028 to Apr 2, 2032 Eligibility criteria expanded, about 30 words · Secondary endpoints: 28 to 30v25 Show 2 more changesShow less
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 28 to 30

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 17 to 18v24
  9. Study sites: 16 to 17v23
  10. Study sites: 14 to 16v22
  11. Study sites: 13 to 14v21
  12. Study sites: 12 to 13v20
  13. Re-verified, no change to tracked fieldsv19
  14. Study sites: 11 to 12 Primary and study completion dates: Oct 2028 to Oct 4, 2028 · Eligibility criteria expanded, about 51 words · Secondary endpoints: 32 to 28v18 Show 3 more changesShow less
    • Primary and study completion dates: Oct 2028 to Oct 4, 2028
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints: 32 to 28

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 10 to 11v17
  16. Study sites: 9 to 10v16
  17. Study sites: 3 to 9v15
  18. 3 versions Re-verified since May 15, 2024, no change to tracked fieldsv12-v14
  19. Start date: Oct 2, 2023 to Jan 30, 2024v11
  20. Study sites: 2 to 3v10
  21. 2 versions Re-verified since Feb 6, 2024, no change to tracked fieldsv8-v9
  22. Site details revised at 1 of 2 sitesv7
  23. Study sites: 1 to 2v6
  24. Re-verified, no change to tracked fieldsv5
  25. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  26. Start date: Dec 2023 to Oct 2, 2023v3
  27. Study sites: 0 to 1v2
  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 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.
Trial Details
NCT Number NCT06003387
Lead Sponsor CSL Behring
Conditions Hemophilia B
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov