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NCT05821959 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
A Phase 1 study of Sensorineural Hearing Loss, Bilateral, sponsored by Akouos.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 9
- Study locations
NCT05821959: Recruiting Phase 1 study of Sensorineural Hearing Loss, Bilateral, sponsored by Akouos.
NCT05821959 is a Phase 1 study of Sensorineural Hearing Loss, Bilateral that is actively recruiting participants, run by Akouos. The registered enrollment target is 22 participants, below the 102-participant average among 4 other Sensorineural Hearing Loss, Bilateral trials with a reported enrollment target (78% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05821959, a Phase 1 study of Sensorineural Hearing Loss, Bilateral, is actively recruiting participants, sponsored by Akouos.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Primary Outcome
AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery system)
Conditions Studied
Interventions
- COMBINATION_PRODUCT AAVAnc80-hOTOF via Akouos Delivery Device
- COMBINATION_PRODUCT AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
Study Locations (9)
California
- University of California, San Francisco Benioff Children's Hospital - San Francisco
Iowa
- University of Iowa - Iowa City
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Tennessee
- Vanderbilt Bill Wilkerson Center - Nashville
Ontario
- The Hospital for Sick Children Jaina.negandhi@sickkids.ca +1 (416) 813 6683 - Toronto
Other
- National Taiwan University Hospital - Taipei
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-09-15 |
| Est. Completion | 2028-10 |
| Phase | Phase 1 |
What NCT05821959 shows while recruiting
NCT05821959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 102-participant average among 4 other Sensorineural Hearing Loss, Bilateral trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Sensorineural Hearing Loss, Bilateral appearing as the primary indexed condition, and to 2 interventions - of which AAVAnc80-hOTOF via Akouos Delivery Device is the first listed.
NCT05821959 lists 9 locations in 9 states (California, Iowa, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05821959 about?
NCT05821959 is a clinical study titled "Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss". 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 intende...
What is the current status of trial NCT05821959?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2023-09-15. Estimated completion is 2028-10.
What conditions does trial NCT05821959 study?
This clinical trial studies the following conditions: Sensorineural Hearing Loss, Bilateral.
What interventions are being tested in trial NCT05821959?
The interventions under investigation include: AAVAnc80-hOTOF via Akouos Delivery Device (COMBINATION_PRODUCT), AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05821959?
This trial is sponsored by Akouos, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05821959 being conducted?
This trial has 9 study locations across California, Iowa, Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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