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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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Part A of this trial will evaluate the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos Delivery Device, together with the Precision Delivery Mechanism, to safely achieve the intended product performance.
The following two dose levels will be tested:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a and Cohort 1b | Experimental | Cohort 1a: Two 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: Up to six eligible participants will be enrolled to receive intracochlear administration of AAVAnc80-hOTOF (dose level 1) in the study ear using a sterile, one-time use investigational medical device; the first three participants will be at least two years of age at the time of AAVAnc80-hOTOF administration and the next three participants may be of any age |
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| Cohort 2 | Experimental | Cohort 2: Up to six eligible participants will be enrolled to receive intracochlear administration of AAVAnc80-hOTOF (dose level 2) in the study ear using a sterile, one-time use investigational medical device; the first three participants will be at least two years of age at the time of AAVAnc80-hOTOF administration and the next three participants may be of any age |
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| Bilateral Expansion | Experimental | Bilateral Expansion: up to eight eligible participants of any age, and no cochlear implants, may be eligible for enrollment into the Bilateral Expansion Cohort (simultaneous bilateral administration of AAVAnc80-hOTOF). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAVAnc80-hOTOF via Akouos Delivery Device | Combination Product | AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time unilateral intracochlear administration using the Akouos Delivery Device. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (AEs) | AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery system) | through trial completion, approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Brainstem Response (ABR) Threshold | Changes from baseline in ABR intensity threshold (decibels normal hearing level [dB nHL]) | through trial completion, approximately 1 year |
| Performance of the Akouos Delivery Device and Precision Delivery Mechanism |
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Criteria for Inclusion:
Criteria for Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akouos Clinical Trials | Contact | +1 857-410-1816 | AkouosClinicalTrials@Lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Marks, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco Benioff Children's Hospital | Recruiting | San Francisco | California | 94158 | United States |
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| AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism | Combination Product | AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time bilateral intracochlear administration using the Akouos Delivery Device together with the Precision Delivery Mechanism. |
|
Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-hOTOF to the intracochlear space |
| through trial completion, approximately 1 year |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19146 | United States |
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| Vanderbilt Bill Wilkerson Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| The Hospital for Sick Children Jaina.negandhi@sickkids.ca +1 (416) 813 6683 | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| University College London | Recruiting | London | United Kingdom | NW1 2PG | United Kingdom |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| C563396 | Deafness, Autosomal Recessive 9 |
| C538268 | Auditory neuropathy |
| D003638 | Deafness |
| D034381 | Hearing Loss |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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