[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544551":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":79,"collaborators":28,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":28,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":109,"overallStatus":46,"whyStopped":28,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Sensorion","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation - Low dose group","EXPERIMENTAL","Intracochlear administration of a Low dose of SENS-501 in one ear, with a dedicated administration system",[13],"Combination Product: SENS-501 administration",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose escalation - High dose group","Intracochlear administration of a High dose of SENS-501 in one ear, with a dedicated administration system",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose expansion group","Intracochlear administration of SENS-501 in one ear, with a dedicated administration system, at the dose recommended following the Dose escalation phase",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"COMBINATION_PRODUCT","SENS-501 administration","Administration of SENS-501 with a dedicated administration system",[15,9,19],null,[30],{"name":31,"affiliation":32,"role":33},"Natalie LOUNDON, Pr","Hopital Necker Enfants Malades","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Lionel HOVSEPIAN, MD","CONTACT","+33 7 86 31 13 76","lionel.hovsepian@sensorion-pharma.com",{"name":41,"role":37,"phone":28,"phoneExt":28,"email":42},"Géraldine HONNET, MD","geraldine.honnet@sensorion-pharma.com",[44,64],{"facility":45,"status":46,"city":47,"state":28,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Childrens Hospital Westmead","RECRUITING","Westmead","NSW 2145","Australia","AU",{"type":52,"coordinates":53},"Point",[54,55],150.98768,-33.80383,{"lat":55,"lon":54},[58,62],{"name":59,"role":37,"phone":60,"phoneExt":28,"email":61},"Clinical Research Coordinator\u002FNurse","+61 2 7825 3048","SCHN-CHW-CRC@health.nsw.gov.au",{"name":63,"role":37,"phone":28,"phoneExt":28,"email":28},"Catherine Birman, Pr",{"facility":32,"status":46,"city":65,"state":28,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Paris","75015","France","FR",{"type":52,"coordinates":70},[71,72],2.3488,48.85341,{"lat":72,"lon":71},[75,78],{"name":31,"role":37,"phone":76,"phoneExt":28,"email":77},"+33(0)171396782","secretariat.loundon@nck.aphp.fr",{"name":31,"role":37,"phone":28,"phoneExt":28,"email":28},{"type":80,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100544551","phase-1-a-phase-iii-clinical-trial-with-sens-501-in-children-suffering-from-severe-to-profound-hearing-loss-due-to-otoferlin-otof-mutations-100544551",false,"NCT06370351","A Phase I\u002FII Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations","A Phase I\u002FII, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children with Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations","AUDIOGENE","Inclusion Criteria:\n\n* Children (male or female) ≥ 6 to ≤ 31 months at the time of inclusion\n* Severe to profound hearing loss assessed by auditory brainstem response (ABR)\n* Biallelic mutation in the Otoferlin gene\n* Presence of Otoacoustic emissions (OAEs)\n* Documented normal cochlea and internal auditory canals\n* Patients with intact vestibular function\n\nExclusion Criteria:\n\n* History of chronic, acute, or major disease, or unspecified reasons, that in the opinion of the Investigator, makes the participant unsuitable for participation in the study or constitutes an unacceptable risk.\n* Have been dosed in a previous gene therapy clinical trial\n* Patients with a prior or current cochlear implant\n* Any contraindication to the surgery determined by the surgeon or anesthesia determined by the anesthesiologist, or designee, or history of therapy known as ototoxic (e.g., cisplatin, high dose and long treatment with aminoglycosides, etc.) for an extended period (more than 2 weeks).\n* Participation in any other interventional clinical trial\n* Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study or might interfere with the evaluation of study treatment\n* Anticipated noncompliance with the protocol requirements","ALL","6 Months","31 Months",{"count":93,"type":94},12,"ESTIMATED","INTERVENTIONAL",[97,98],"PHASE1","PHASE2","This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.",[101,102,103,104,105,106,107,108],"OTOF Gene Mutation","DFNB9","Congenital Deafness","Hearing Disorders","Ear Diseases","Otorhinolaryngologic Diseases","Deafness","Hearing Loss, Sensorineural",[101,110,107,111,87,112,102,113,114,115,116,117],"Hearing impairment","otoferlin","Hearing Loss","Hearing disorder","Cochlear implant","SENS-501","Congenital Hearing loss","Gene therapy","2024-09-23",{"date":120,"type":121},"2024-09-26","ACTUAL",{"date":123,"type":121},"2024-06-21",{"date":125,"type":94},"2031-07",{"name":5,"class":6},2]