Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B

Record History

1. Minor Oct 5, 2026 Study sites: 14 to 16 Eligibility criteria revised Show 1 more changeShow less

   • Eligibility criteria revised
2. Minor Sep 15, 2026 Study sites: 13 to 14 Eligibility criteria expanded, about 28 words · Secondary endpoints: details revised at 12 of 31 entries Show 2 more changesShow less

   • Eligibility criteria expanded, about 28 words
   • Secondary endpoints: details revised at 12 of 31 entries
3. Minor Aug 4, 2026 Study sites: 12 to 13v13
4. Minor Jul 17, 2026 Trial sites expanded: 2 → 12 locations Secondary endpoints: details revised at 1 of 31 entriesv12 Show 1 more changeShow less

   • Secondary endpoints: details revised at 1 of 31 entries
5. Minor Jun 3, 2026 Secondary endpoints revised (31) Study title revised · Eligibility criteria expanded, about 1 wordv11 Show 2 more changesShow less

   • Study title revised
   • Eligibility criteria expanded, about 1 word

   See this version in full on ClinicalTrials.gov ↗

6. Minor May 22, 2026 Trial sites reduced: 11 → 2 locations Eligibility criteria revised · Secondary endpoints revised (31) · Study title revisedv10 Show 3 more changesShow less

   • Eligibility criteria revised
   • Secondary endpoints revised (31)
   • Study title revised

   See this version in full on ClinicalTrials.gov ↗

7. Minor May 8, 2026 Study sites: 10 to 11v9
8. Minor Apr 15, 2026 Study sites: 9 to 10v8
9. Minor Apr 1, 2026 Study sites: 8 to 9v7
10. Minor Mar 25, 2026 Study sites: 7 to 8 Eligibility criteria revised · Secondary endpoints revised (31) · Study title revisedv6 Show 3 more changesShow less

    • Eligibility criteria revised
    • Secondary endpoints revised (31)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

11. Minor Feb 3, 2026 Study sites: 6 to 7 Eligibility criteria revised · Secondary endpoints revised (31) · Study title revisedv5 Show 3 more changesShow less

    • Eligibility criteria revised
    • Secondary endpoints revised (31)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

12. Minor Jan 23, 2026 Study sites: 2 to 6v4
13. Minor Dec 12, 2025 Enrollment target: 18 to 20 Eligibility criteria expanded, about 28 words · Secondary endpoints revised (31)v3 Show 2 more changesShow less

    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints revised (31)

    See this version in full on ClinicalTrials.gov ↗

14. Notable Aug 4, 2025 Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jul 31, 2025 to Jul 28, 2025v2 Show 2 more changesShow less

    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 31, 2025 to Jul 28, 2025
15. Minor Jul 15, 2025 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.