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A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv40
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 144 to confirmed 154 · Site details revised at 50 of 50 sitesv39 Show 2 more changesShow less
    • Enrollment target: estimated 144 to confirmed 154
    • Site details revised at 50 of 50 sites
  3. Study sites: 52 to 50v38
  4. Study sites: 51 to 52v37
  5. Re-verified, no change to tracked fieldsv36
Show 34 earlier versionsHide 34 earlier versions
  1. Study sites: 50 to 51v35
  2. Study sites: 49 to 50v34
  3. Study sites: 48 to 49v33
  4. Study sites: 46 to 48v32
  5. Study sites: 43 to 46v31
  6. Study sites: 41 to 43v30
  7. Study sites: 39 to 41v29
  8. Study sites: 36 to 39v28
  9. Study sites: 34 to 36v27
  10. Study sites: 33 to 34v26
  11. Study sites: 32 to 33v25
  12. Study sites: 31 to 32v24
  13. Study sites: 29 to 31v23
  14. Study sites: 27 to 29v22
  15. Primary completion date: Oct 2024 to Dec 2026 Enrollment target: 114 to 144 · Study sites: 26 to 27 · Completion date: Dec 2024 to Mar 2027 · 2 morev21 Show 5 more changesShow less
    • Enrollment target: 114 to 144
    • Study sites: 26 to 27
    • Completion date: Dec 2024 to Mar 2027
    • Secondary endpoints: 6 to 5
    • Study description expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 24 to 26v20
  17. Study sites: 20 to 24v19
  18. Study sites: 19 to 20v18
  19. Eligibility criteria revisedv17 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 18 to 19v16
  21. Study sites: 16 to 18v15
  22. Study sites: 14 to 16v14
  23. Study sites: 13 to 14v13
  24. Study sites: 12 to 13v12
  25. Study sites: 10 to 12v11
  26. Study sites: 9 to 10v10
  27. Study sites: 8 to 9v9
  28. Study sites: 7 to 8v8
  29. Study sites: 6 to 7v7
  30. Study sites: 5 to 6v6
  31. Study sites: 4 to 5v5
  32. Study sites revised (4)v4 See this version in full on ClinicalTrials.gov ↗
  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Jun 2022 to Jul 13, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Jun 2022 to Jul 13, 2022
  34. Start date: May 2022 to Jun 2022v2
  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.
The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).
Trial Details
NCT Number NCT05392114
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Hereditary Angioedema
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov