CTIS2024-512584-31-00
Active, not recruiting
Phase 1
An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-hOTOF Gene Therapy in Individuals with Sensorineural Hearing Loss due to Otoferlin Gene (OTOF) Mutations - AK-OTOF-LTF
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Otoferlin gene-mediated hearing loss
- Sponsor
- Akouos Inc.
- Enrollment
- 14
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals with OTOF\-mediated hearing loss who received an intracochlear administration of AAVAnc80\- hOTOF in the AK\-OTOF\-101 clinical trial (either Part A or Part B)., 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. Potential participants will not be excluded based on their sex, gender, race, or ethnicity.
Outcomes
Primary Outcomes
Not specified
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