[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502415":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":187,"collaborators":189,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":29,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":29,"maxAge":29,"enrollmentInfo":199,"targetDuration":29,"studyType":202,"phases":203,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":48,"whyStopped":29,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"Akouos, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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\n\nCohort 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",[13],"Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","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",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Bilateral Expansion","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).",[22],"Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism",[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"COMBINATION_PRODUCT","AAVAnc80-hOTOF via Akouos Delivery Device","AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time unilateral intracochlear administration using the Akouos Delivery Device.",[9,15],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism","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.",[19],[35],{"name":36,"affiliation":37,"role":38},"Peter Marks, MD","Eli Lilly and Company","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":44},"Akouos Clinical Trials","CONTACT","+1 857-410-1816","AkouosClinicalTrials@Lilly.com",[46,65,80,95,110,125,140,157,173],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of California, San Francisco Benioff Children's Hospital","RECRUITING","San Francisco","California","94158","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.41942,37.77493,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":63,"phoneExt":29,"email":64},"Jenny Stephans","415-353-2012","Jihyun.Stephans@ucsf.edu",{"facility":66,"status":48,"city":67,"state":68,"zip":69,"country":52,"countryCode":53,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of Iowa","Iowa City","Iowa","52242",{"type":55,"coordinates":71},[72,73],-91.53017,41.66113,{"lat":73,"lon":72},[76],{"name":77,"role":42,"phone":78,"phoneExt":29,"email":79},"Kesten Anderson","+1 319-356-8320","Kesten-Anderson@uiowa.edu",{"facility":81,"status":48,"city":82,"state":83,"zip":84,"country":52,"countryCode":53,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":55,"coordinates":86},[87,88],-71.05977,42.35843,{"lat":88,"lon":87},[91],{"name":92,"role":42,"phone":93,"phoneExt":29,"email":94},"Meghan Fitzgerald","+1 617-355-4729","OTOFtrial@childrens.harvard.edu",{"facility":96,"status":48,"city":97,"state":98,"zip":99,"country":52,"countryCode":53,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":55,"coordinates":101},[102,103],-84.51439,39.12711,{"lat":103,"lon":102},[106],{"name":107,"role":42,"phone":108,"phoneExt":29,"email":109},"Alexandra Sestito","+1 513 636-4355","alexandra.sestito@cchmc.org",{"facility":111,"status":48,"city":112,"state":113,"zip":114,"country":52,"countryCode":53,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19146",{"type":55,"coordinates":116},[117,118],-75.16362,39.95238,{"lat":118,"lon":117},[121],{"name":122,"role":42,"phone":123,"phoneExt":29,"email":124},"Aminat Adegbuji","+1 267-426-8380","adegbujia@chop.edu",{"facility":126,"status":48,"city":127,"state":128,"zip":129,"country":52,"countryCode":53,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Vanderbilt Bill Wilkerson Center","Nashville","Tennessee","37232",{"type":55,"coordinates":131},[132,133],-86.78444,36.16589,{"lat":133,"lon":132},[136],{"name":137,"role":42,"phone":138,"phoneExt":29,"email":139},"Taha Jan, MD","+1 615-421-1228","taha.a.jan@vumc.org",{"facility":141,"status":48,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"The Hospital for Sick Children Jaina.negandhi@sickkids.ca +1 (416) 813 6683","Toronto","Ontario","M5G 1X8","Canada","CA",{"type":55,"coordinates":148},[149,150],-79.39864,43.70643,{"lat":150,"lon":149},[153],{"name":154,"role":42,"phone":155,"phoneExt":29,"email":156},"Jaina Negandhi","+1 416-813-6683","Jaina.negandhi@sickkids.ca",{"facility":158,"status":48,"city":159,"state":29,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"National Taiwan University Hospital","Taipei","100","Taiwan","TW",{"type":55,"coordinates":164},[165,166],121.52639,25.05306,{"lat":166,"lon":165},[169],{"name":170,"role":42,"phone":171,"phoneExt":29,"email":172},"Wan-Cian Liao","+886- 953-728-657","mulong0328@gmail.com",{"facility":174,"status":48,"city":175,"state":176,"zip":177,"country":176,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"University College London","London","United Kingdom","NW1 2PG","UK",{"type":55,"coordinates":180},[181,182],-0.12574,51.50853,{"lat":182,"lon":181},[185],{"name":29,"role":42,"phone":29,"phoneExt":29,"email":186},"UCLH.OTOF.Study@nhs.net",{"type":188,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[190],{"name":37,"class":6},"100502415","phase-1-gene-therapy-trial-for-otoferlin-gene-mediated-hearing-loss-100502415",false,"NCT05821959","Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss","A Trial of AAVAnc80-hOTOF Gene Therapy in Individuals With Sensorineural Hearing Loss Due to Otoferlin Gene Mutations","Criteria for Inclusion:\n\n1. Participants may be of any age, based on Cohort Criteria\n2. At least two mutations in the otoferlin gene\n3. Clinical presentation of Profound bilateral sensorineural hearing loss as assessed by ABR\n4. Preserved distortion product otoacoustic emissions (DPOAEs)\n5. Able and willing to comply with all study requirements, including willingness to participate in a separate long term follow-up study after completion of this trial\n\nCriteria for Exclusion:\n\n1. Persistent ear infections, anatomic or other abnormalities of the ear, and\u002For medical conditions that would contraindicate undergoing surgery, anesthesia, and\u002For administration of investigational gene therapy\n2. Cochlear Implant(s) in the ear(s) to receive AAVAnc80-hOTOF\n3. Prior participation in a clinical trial with an investigational drug, within six months prior to administration, or any prior participation in a gene therapy clinical trial","ALL",{"count":200,"type":201},22,"ESTIMATED","INTERVENTIONAL",[204,205],"PHASE1","PHASE2","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.",[208],"Sensorineural Hearing Loss, Bilateral",[210,211,212,213,214,215],"Otoferlin","Auditory neuropathy (AN)","Deafness, autosomal recessive 9 (DFNB9)","Hearing loss","Hearing loss, bilateral","Hearing loss, sensorineural","2026-03-03",{"date":218,"type":219},"2026-03-04","ACTUAL",{"date":221,"type":219},"2023-09-15",{"date":223,"type":201},"2028-10",{"name":5,"class":6},9]