[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06696456":3,"trial-entities:NCT06696456":110,"trial-summary:NCT06696456":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":34,"secondary_outcomes":39,"sex":43,"minimum_age":28,"maximum_age":28,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":52,"locations":56,"central_contacts":99,"overall_officials":100,"references":105,"see_also_links":106},"NCT06696456","AK-OTOF-LTFU","Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy","An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-hOTOF Gene Therapy in Individuals With Sensorineural Hearing Loss Due to Otoferlin Gene Mutations","ENROLLING_BY_INVITATION","2033-04","2026-02","2026-04-06","2024-11-11","Akouos, Inc.","INDUSTRY",true,"This multi-center, observational, post-intervention long term follow-up (LTFU) study will monitor for safety and efficacy of AAVAnc80-hOTOF in individuals with sensorineural hearing loss due to otoferlin gene mutations who have previously received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial.","After completing one year of initial safety and efficacy assessments following an intracochlear administration of AAVAnc80-hOTOF in AK-OTOF-101, participants will continue to be observed for an additional approximately four years of safety and efficacy follow-up in this LTFU study, for a total of approximately five years of safety and efficacy observations after vector administration. For each participant, evaluations in the LTFU study will occur at approximately one and a half years and two years after vector administration, followed by annual visits through Year 5; the duration in this LTFU study is approximately four years, with the aim of understanding and mitigating any risks related to delayed adverse events, as well as characterizing the durability of effect of the AAVAnc80-hOTOF.",[19],"Otoferlin Gene-mediated Hearing Loss",[21,22,23,24,25,26],"Otoferlin","Deafness, autosomal recessive 9 (DFNB9)","Hearing loss","Hearing loss, bilateral","Hearing loss, sensorineural","Auditory neuropathy (AN)","OBSERVATIONAL",null,[],{"count":31,"type":32},30,"ESTIMATED",[],[35],{"measure":36,"description":37,"timeFrame":38},"Long term safety of AAVAnc80-hOTOF, including the incidence and frequency of late-occurring adverse events (AEs)","The following adverse events will be collected:\n\n1. The development of new or exacerbation of malignancies (oncologic), neurologic, rheumatologic or other autoimmune, hematologic disorders, or new infections (if the infection is potentially related to AAVAnc80-hOTOF\n2. AEs that are related to AAVAnc80-hOTOF and\u002For the administration procedure\n3. AEs of special interest\n4. All serious adverse events regardless of severity or of relationship to participation in the AK-OTOF-101 Clinical Trial","Through study completion, approximately four years.",[40],{"measure":41,"description":42,"timeFrame":38},"Auditory Brainstem Response (ABR) Threshold","Changes in ABR intensity threshold (decibels normal hearing level \\[dB nHL\\])","ALL",false,{"inclusion":46,"exclusion":49,"raw_text":51},[47,48],"Individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial","Legally authorized representative and\u002For participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate)",[50],"Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and\u002For, in the opinion of the Investigator, makes the potential participant unsuitable for the study","Inclusion Criteria:\n\n* Individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial\n* Legally authorized representative and\u002For participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate)\n\nExclusion Criteria:\n\n* Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and\u002For, in the opinion of the Investigator, makes the potential participant unsuitable for the study",[53,54,55],"CHILD","ADULT","OLDER_ADULT",[57,66,74,82,91],{"facility":58,"city":59,"state":60,"zip":61,"country":62,"geoPoint":63},"University of Iowa","Iowa City","Iowa","52242","United States",{"lat":64,"lon":65},41.66113,-91.53017,{"facility":67,"city":68,"state":69,"zip":70,"country":62,"geoPoint":71},"Boston Children's Hospital","Boston","Massachusetts","02115",{"lat":72,"lon":73},42.35843,-71.05977,{"facility":75,"city":76,"state":77,"zip":78,"country":62,"geoPoint":79},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19146",{"lat":80,"lon":81},39.95238,-75.16362,{"facility":83,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Hospital Sant Joan de Déu","Esplugues de Llobregat","Barcelona","08950","Spain",{"lat":89,"lon":90},41.37732,2.08809,{"facility":92,"city":93,"state":94,"zip":95,"country":94,"geoPoint":96},"National Taiwan University Hospital","Taipei","Taiwan","(R.O.C), 100",{"lat":97,"lon":98},25.05306,121.52639,[],[101],{"name":102,"affiliation":103,"role":104},"Peter Marks, M.D.","Eli Lilly and Company","STUDY_DIRECTOR",[],[107],{"label":108,"url":109},"AK-OTOF-101: Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss","https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT05821959?cond=otoferlin&rank=3",{"nct_id":4,"conditions":111,"biomarkers":114},[112,19,113],"Auditory Neuropathy Spectrum Disorder","Sensorineural Hearing Loss",[],{"nct_id":4,"found":44,"summary":28,"prompt_version":28}]