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Global Open-Label Extension Study of Del-desiran for the Treatment of DM1

Study acronym: HARBOR-OLE
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Aug 2030 → Oct 2030
Enrollment reduced 13% 230 → 199 participants
See other at-risk trials from Avidity Biosciences, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2030 to Oct 2030
    • Enrollment reduced: 230 → 199 participants
    v8
  2. Trial sites expanded: 26 → 35 locations
    • Start date: Jul 25, 2025 to Jun 26, 2025
    v7
  3. Trial sites expanded: 20 → 26 locationsv6
  4. Study sites: 14 to 20v5
  5. Enrollment target: 217 to 230
    • Study sites: 9 to 14
    • Eligibility criteria expanded, about 104 words
    • Study description expanded, about 16 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 6 to 9v3
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 6
    • Start date changed from estimate of Jul 2025 to Jul 25, 2025
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC 1001) for the Treatment of Myotonic Dystrophy Type 1
Trial Details
NCT Number NCT07008469
Lead Sponsor Avidity Biosciences, Inc.
Conditions
(from sponsor)		 Myotonic Dystrophy Type 1, DM1, Myotonic Dystrophy, Myotonia, Myotonic Dystrophy 1, Myotonic Disorders, Steinert Myotonic Dystrophy, Steinert Disease
Related terms Myotonia, Myotonic Disorders, Myotonic Dystrophy
Enrollment 199 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov