By InvitationNot Applicable

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

United States, Spain, Taiwan30 participantsStarted 2024-11-11

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

What they're measuring

Long term safety of AAVAnc80-hOTOF, including the incidence and frequency of late-occurring adverse events (AEs)

Timeframe: Through study completion, approximately four years.

Trial details

NCT IDNCT06696456

SponsorAkouos, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2033-04

View on ClinicalTrials.gov More Otoferlin Gene-mediated Hearing Loss trials