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Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 4 to 5v6
  2. Re-verified, no change to tracked fieldsv5
  3. Study sites: 3 to 4v4
  4. Study sites: 2 to 3v3
  5. Study sites: 1 to 2v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multi-center, observational, post-intervention long term follow-up (LTFU) study will monitor for safety and efficacy of AAVAnc80-hOTOF in individuals with sensorineural hearing loss due to otoferlin gene mutations who have previously received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial.
Trial Details
NCT Number NCT06696456
Lead Sponsor Akouos, Inc.
Collaborators: Eli Lilly and Company
Conditions
(from sponsor)		 Otoferlin Gene-mediated Hearing Loss
Related terms Auditory neuropathy, Deafness, Deafness, Autosomal Recessive 9, Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov