Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

Description

Part A of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

Conditions

Sensorineural Hearing Loss, Bilateral

Study Overview

Study Details

Study overview

Part A of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

A Trial of AAVAnc80-hOTOF Gene Therapy in Individuals with Sensorineural Hearing Loss Due to Otoferlin Gene Mutations

Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

Condition
Sensorineural Hearing Loss, Bilateral
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Akouos, Inc.,

    Kathy Reape, MD, STUDY_DIRECTOR, Akouos, Inc.

    Study Record Dates

    2028-10