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Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Sponsor: Akouos, Inc.
Summary
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.
Official title: An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-hOTOF Gene Therapy in Individuals With Sensorineural Hearing Loss Due to Otoferlin Gene Mutations
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2024-11-11
Completion Date
2033-04
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Locations (5)
University of Iowa
Iowa City, Iowa, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
National Taiwan University Hospital
Taipei, Taiwan, Taiwan