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A Non-interventional Cohort Safety Study of Patients With hATTR-PN

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 16% 240 → 202 participants
See other at-risk trials from Ionis Pharmaceuticals

Record History

  1. Enrollment closed, study ongoing Enrollment reduced: 240 → 202 participants · Site details revised at 26 of 26 sitesv29 Show 2 more changesShow less
    • Enrollment reduced: 240 → 202 participants
    • Site details revised at 26 of 26 sites
  2. Eligibility criteria expanded, about 8 words Secondary endpoints: details revised at 2 of 2 entries · Site details revised at 4 of 26 sites · Study description shortened, about 1 wordv28 Show 3 more changesShow less
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 4 of 26 sites
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 25 to 26v27
  4. Study sites: 24 to 25v26
  5. Study sites: 35 to 24v25
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 39 to 35v24
  2. Re-verified, no change to tracked fieldsv23
  3. Study sites: 38 to 39v22
  4. Study sites: 37 to 38v21
  5. Study sites: 35 to 37v20
  6. Study sites: 34 to 35v19
  7. Study sites: 31 to 34v18
  8. Study sites: 30 to 31v17
  9. Study sites: 29 to 30v16
  10. Study sites: 28 to 29v15
  11. Study sites: 23 to 28v14
  12. Study sites: 22 to 23v13
  13. Study sites: 21 to 22v12
  14. Study sites: 20 to 21v11
  15. Study sites: 18 to 20v10
  16. Study sites: 15 to 18v9
  17. Study sites: 6 to 15v8
  18. Study sites: 5 to 6v7
  19. Study sites: 4 to 5v6
  20. Study sites: 3 to 4v5
  21. Re-verified, no change to tracked fieldsv4
  22. Study sites: 2 to 3 Start date changed from estimate of Sep 30, 2021 to Sep 21, 2021v3 Show 1 more changeShow less
    • Start date changed from estimate of Sep 30, 2021 to Sep 21, 2021
  23. Trial status: Not Yet Recruiting to Recruiting Start date: May 31, 2021 to Sep 30, 2021 · Study sites: 0 to 2v2 Show 2 more changesShow less
    • Start date: May 31, 2021 to Sep 30, 2021
    • Study sites: 0 to 2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, non-interventional, Long-term, multinational cohort safety study of patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). The overarching goal of this study is to further characterize the long-term safety of TEGSEDI (inotersen) in patients with hATTR-PN under real-world conditions.
Trial Details
NCT Number NCT04850105
Lead Sponsor Akcea Therapeutics
Collaborators: United BioSource, LLC
Conditions Hereditary Transthyretin Amyloidosis With Polyneuropthy
Enrollment 202 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov