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NCT06696456

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

Enrolling by Invitation
Not specifiedAll AgesObservational
Akouos, Inc.
~30 participants
Updated 2026-04-06 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long term safety of AAVAnc80-hOTOF, including the incidence and frequency of late-occurring adverse events (AEs)
Measured over Through study completion, approximately four years.

Conditions

Otoferlin Gene-mediated Hearing Loss

Explore related trials

Auditory Neuropathy Spectrum DisorderOtoferlin Gene-mediated Hearing LossSensorineural Hearing Loss

Where it's being run

5 sites across 5 states
Iowa1
Massachusetts1
Pennsylvania1
Barcelona1
Taiwan1

Study leadership

  • Peter Marks, M.D. · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

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

    The following adverse events will be collected: 1. The development of new or exacerbation of malignancies (oncologic), neurologic, rheumatologic or other autoimmune, hematologic disorders, or new infections (if the infection is potentially related to AAVAnc80-hOTOF 2. AEs that are related to AAVAnc80-hOTOF and/or the administration procedure 3. AEs of special interest 4. All serious adverse events regardless of severity or of relationship to participation in the AK-OTOF-101 Clinical Trial