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A Phase 3 Study of NTLA-2001 in ATTRv-PN

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Active, Not Recruiting to Recruitingv19 Show 4 more changesShow less
    • Enrollment target: 50 to 60
    • Study sites: 16 to 14
    • Study description revised
    • Eligibility criteria expanded, about 4 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 16 of 16 sites
    v18
  3. Study sites: 15 to 16v17
  4. Site details revised at 3 of 15 sitesv16
  5. Study sites: 14 to 15v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 13 to 14v14
  2. Study sites: 12 to 13v13
  3. Study sites: 11 to 12v12
  4. Study sites: 9 to 11v11
  5. Study sites: 8 to 9v10
  6. Study sites: 7 to 8v9
  7. Study sites: 6 to 7v8
  8. Study sites: 5 to 6v7
  9. Study sites: 4 to 5v6
  10. Study sites: 2 to 4v5
  11. Study sites: 1 to 2v4
  12. Start date changed from estimate of Nov 2024 to Nov 22, 2024v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will be conducted to evaluate the efficacy and safety of a single dose of nexiguran ziclumeran (NTLA-2001) compared to placebo in participants with ATTRv-PN.
Trial Details
NCT Number NCT06672237
Lead Sponsor Intellia Therapeutics
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Neuromuscular Disease, Neuromuscular Diseases (NMD), Neurodegenerative Disease, Neurodegenerative Disease, Hereditary, Neurodegenerative Diseases, Neuromuscular Diseases, Nerve Disorders, Nervous System Disease +12 more
Related terms Amyloid Neuropathies, Amyloid Neuropathies, Familial, Amyloidosis, Amyloidosis, Familial, Amyloidosis, Hereditary, Transthyretin-Related, Genetic Diseases, Inborn, Heredodegenerative Disorders, Nervous System, Metabolic Diseases, Metabolism, Inborn Errors, Nervous System Diseases, Neurodegenerative Diseases, Neuromuscular Diseases, Peripheral Nervous System Diseases, Polyneuropathies
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov