2024-512584-31-00
Recruiting
Phase 2/3
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
Overview
- Phase
- Phase 2/3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Akouos Inc.
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Safety: Incidence and frequency of AEs
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
To evaluate the long term safety of AAVAnc80-hOTOF, including late-occurring adverse events.
Investigators
Akouos Clinical Trials
Scientific
Akouos Inc.
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
Safety: Incidence and frequency of AEs
Safety: Incidence and frequency of AEs
Safety: Concomitant Medications
Safety: Concomitant Medications
Safety: Clinical labs: chemistries, hematology (CBC with differential), urinalysis
Safety: Clinical labs: chemistries, hematology (CBC with differential), urinalysis
Safety: Physical examination and vital signs
Safety: Physical examination and vital signs
Safety: Otoscopic examination
Safety: Otoscopic examination
Safety: Vestibular screening
Safety: Vestibular screening
Safety: Tympanometry
Safety: Tympanometry
Secondary Outcomes
- Efficacy: Diagnostic ABR testing threshold
- Efficacy: Age-appropriate behavioral audiometry
- Efficacy: Standard word or speech recognition testing
- Efficacy: Standard auditory questionnaires
Study Sites (1)
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