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A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

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

Record History

  1. Minor 2 versions Re-verified since Nov 19, 2024, no change to tracked fieldsv24-v25
  2. Notable Primary and study completion dates: Jul 2024 to Aug 2029 Primary endpoints: 13 to 14 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 140 to confirmed 151 · 2 morev23 Show 5 more changesShow less
    • Primary endpoints: 13 to 14
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 140 to confirmed 151
    • Study sites: 34 to 33
    • Study description expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study sites: 32 to 34v22
  4. Minor Study sites: 31 to 32v21
  5. Minor Study sites: 30 to 31v20
Show 18 earlier versionsHide 18 earlier versions
  1. Minor Study sites: 29 to 30v19
  2. Minor Study sites: 23 to 29v18
  3. Minor Re-verified, no change to tracked fieldsv17
  4. Minor Study sites: 22 to 23v16
  5. Minor Study sites: 21 to 22v15
  6. Minor Study sites: 20 to 21v14
  7. Minor Study sites: 19 to 20v13
  8. Minor Study sites: 18 to 19v12
  9. Minor Study sites: 17 to 18v11
  10. Minor Study sites: 16 to 17v10
  11. Minor Study sites: 13 to 16v9
  12. Minor Study sites: 12 to 13v8
  13. Minor Study sites: 11 to 12v7
  14. Minor Study sites: 10 to 11v6
  15. Minor Study sites: 9 to 10v5
  16. Minor Study sites: 2 to 9v4
  17. Minor Interventions: ION-682884 (Drug) to Eplontersen (Drug) Eligibility criteria revised · Study description revised · Site contacts updated at 2 of 2 sites · 1 morev3 Show 4 more changesShow less
    • Eligibility criteria revised
    • Study description revised
    • Site contacts updated at 2 of 2 sites
    • Study title expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  18. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Oct 2021 to Jan 4, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 2021 to Jan 4, 2022
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 safety and tolerability of extended dosing with eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).
Trial Details
NCT Number NCT05071300
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Enrollment 151 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov