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

Conditions

• Otoferlin Gene-mediated Hearing Loss

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

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 Dates

Start date

Nov 11, 2024

Status verified

Feb 2026

Primary completion

Apr 30, 2033

Completion

Apr 30, 2033

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: Study Participants
  Individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial

Primary Outcome Measure

Long term safety of AAVAnc80-hOTOF, including the incidence and frequency of late-occurring adverse events (AEs) [ Time Frame: Through study completion, approximately four years. ]

Locations (3)

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