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Clinical Trials in Spain / NCT06696456
Enrolling by invitation Observational

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

NCT06696456 · tracked via the Priya Life Science Spain tracker
Sponsor
Akouos, Inc
Phase
Observational
Started
2024-11-11
Last updated
2026-04-06

Condition(s) studied

Otoferlin Gene-mediated Hearing Loss

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (5)

FacilityCityRegionStatus
University of Iowa Iowa City Iowa
Boston Children's Hospital Boston Massachusetts
Children's Hospital of Philadelphia Philadelphia Pennsylvania
Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona
National Taiwan University Hospital Taipei Taiwan

More Akouos, Inc. trials in Spain

Otoferlin Gene-mediated Hearing Loss Natural History Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06696456 on ClinicalTrials.gov ↗ ← All trials in Spain