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

Enrolling by invitation

Conditions studied: Otoferlin Gene-mediated Hearing Loss

In brief

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.

Key facts

Study ID

NCT06696456

Run by

Akouos, Inc.

People needed

30

Starts

2024-11-11

Expected to finish

2033-04-01

Last updated by the study team

2026-04-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial
• Legally authorized representative and/or participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate)

You may not qualify if…

• Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study

Where it is running

• 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

Full record on ClinicalTrials.gov

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