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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through trial completion, approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through trial completion, approximately 2 years
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
2,618 Previous Clinical Trials
3,201,546 Total Patients Enrolled
Kathy Reape, MDStudy DirectorAkouos, Inc.
1 Previous Clinical Trials
150 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 2 and 17 years old.I have two mutations in my otoferlin gene.I have severe hearing loss in both ears, confirmed by a hearing test.I do not have ear conditions or other health issues that prevent surgery or gene therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 1a and Cohort 1b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for those over 50 years of age to participate in this clinical trial?
"This clinical trial will consider participants aged between two and seventeen."
Answered by AI
Do I meet the qualifications for enrollment in this research project?
"Prospective participants of this medical trial must have sensorineural hearing loss and be between the ages 2 and 17. Aspiring enrollees should note that only 14 slots are available."
Answered by AI
How many participants are actively engaged in this research project?
"Affirmative. According to the information offered on clinicaltrials.gov, this research project is still recruiting patients and was first published April 1st 2023 with an update issued on April 18th of the same year. Currently, 14 participants are needed at one medical centre."
Answered by AI
Are there still open opportunities to enroll in this research?
"Clinicaltrials.gov indicates that recruitment for this clinical trial is ongoing, with an initial posting date of April 1st 2023 and a most recent update from the 18th of April in the same year."
Answered by AI
Who else is applying?
What site did they apply to?
Children's Hospital of Philadelphia
University of Iowa
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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