Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Recruiting now · Phase 1/Phase 2
Conditions studied: Sensorineural Hearing Loss, Bilateral
In brief
Part A of this trial will evaluate the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos Delivery Device, together with the Precision Delivery Mechanism, to safely achieve the intended product performance.
Key facts
- Study ID
- NCT05821959
- Run by
- Akouos, Inc.
- People needed
- 22
- Starts
- 2023-09-15
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California, San Francisco Benioff Children's Hospital — San Francisco, California, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Vanderbilt Bill Wilkerson Center — Nashville, Tennessee, United States (enrolling)
- The Hospital for Sick Children Jaina.negandhi@sickkids.ca +1 (416) 813 6683 — Toronto, Ontario, Canada (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
- University College London — London, United Kingdom, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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