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Virus Therapy

Gene Therapy for Hearing Loss

Phase 1 & 2
Recruiting
Research Sponsored by Akouos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through trial completion, approximately 2 years
Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of a new medical device and treatment for hearing loss.

Who is the study for?
This trial is for children and teens aged 2 to 17 with profound bilateral sensorineural hearing loss due to biallelic mutations in the otoferlin gene. They must be able to follow the study's procedures, including a long-term follow-up. Those with cochlear implants, persistent ear infections, or conditions that make surgery risky can't participate.Check my eligibility
What is being tested?
The trial tests a gene therapy called AAVAnc80-hOTOF delivered through an Akouos device into one ear. It aims to see if it's safe and works as intended at two different dose levels.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to surgery, anesthesia, and gene therapy administration such as inflammation or immune responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through trial completion, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through trial completion, approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Adverse Events (AEs)
Secondary outcome measures
Auditory Brainstem Response (ABR) Threshold
Performance of the Akouos Delivery Device

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Cohort 2: Participants aged 2 to 17 years old (inclusive) at the time of AAVAnc80-hOTOF administration to receive intracochlear administration of AAVAnc80-hOTOF (dose level 2) in the study ear using a sterile, one-time use investigational medical device
Group II: Cohort 1a and Cohort 1bExperimental Treatment1 Intervention
Cohort 1a: Participants aged 7 to 17 years old (inclusive) to receive intracochlear administration of AAVAnc80-hOTOF (dose level 1) in the study ear using a sterile, one-time use investigational medical device Cohort 1b: Participants aged 2 to 17 years old (inclusive) at the time of AAVAnc80-hOTOF administration to receive intracochlear administration of AAVAnc80-hOTOF (dose level 1) in the study ear using a sterile, one-time use investigational medical device

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Who is running the clinical trial?

Akouos, Inc.Lead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,624 Previous Clinical Trials
3,216,907 Total Patients Enrolled
Kathy Reape, MDStudy DirectorAkouos, Inc.
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

AAVAnc80-hOTOF (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05821959 — Phase 1 & 2
Sensorineural Hearing Loss Research Study Groups: Cohort 2, Cohort 1a and Cohort 1b
Sensorineural Hearing Loss Clinical Trial 2023: AAVAnc80-hOTOF Highlights & Side Effects. Trial Name: NCT05821959 — Phase 1 & 2
AAVAnc80-hOTOF (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05821959 — Phase 1 & 2
~9 spots leftby Oct 2028
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