[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06544798":3,"trial-entities:NCT06544798":124,"trial-summary:NCT06544798":128},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":50,"locations":53,"central_contacts":120,"overall_officials":121,"references":122,"see_also_links":123},"NCT06544798","MGT-AQP1-202","Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia","Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia","ENROLLING_BY_INVITATION","2032-02","2025-10","2025-10-16","2024-08-02","MeiraGTx, LLC","INDUSTRY",true,"This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.","Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 in Study MGT-AQP1-202.",[19],"Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},276,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"GENETIC","AAV2-hAQP1","Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland",[34],"Active treatment group",[36],{"measure":37,"timeFrame":38},"Number of participants with study drug-related adverse events and serious adverse events","From study start until Month 60 post-treatment",[],"ALL","18 Years",null,false,{"inclusion":45,"exclusion":47,"raw_text":49},[46],"Received study drug in Study MGT-AQP1-201",[48],"Withdrew consent to participate in Study MGT-AQP1-201.","Inclusion Criteria:\n\n* Received study drug in Study MGT-AQP1-201\n\nExclusion Criteria:\n\n* Withdrew consent to participate in Study MGT-AQP1-201.",[51,52],"ADULT","OLDER_ADULT",[54,63,71,79,87,95,103,111],{"facility":55,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"Banner MD Anderson Cancer Center","Gilbert","Arizona","85234","United States",{"lat":61,"lon":62},33.35283,-111.78903,{"facility":64,"city":65,"state":66,"zip":67,"country":59,"geoPoint":68},"Miami Cancer Institute at Baptist Health South Florida","Miami","Florida","33176",{"lat":69,"lon":70},25.77427,-80.19366,{"facility":72,"city":73,"state":74,"zip":75,"country":59,"geoPoint":76},"University of Iowa","Iowa City","Iowa","52242",{"lat":77,"lon":78},41.66113,-91.53017,{"facility":80,"city":81,"state":82,"zip":83,"country":59,"geoPoint":84},"University of Missouri","Columbia","Missouri","65212",{"lat":85,"lon":86},38.95171,-92.33407,{"facility":88,"city":89,"state":90,"zip":91,"country":59,"geoPoint":92},"Erie County Medical Center","Buffalo","New York","14215",{"lat":93,"lon":94},42.88645,-78.87837,{"facility":96,"city":97,"state":98,"zip":99,"country":59,"geoPoint":100},"Atrium Health","Charlotte","North Carolina","28209",{"lat":101,"lon":102},35.22709,-80.84313,{"facility":104,"city":105,"state":106,"zip":107,"country":59,"geoPoint":108},"Alleghany General Hospital","Pittsburgh","Pennsylvania","15212",{"lat":109,"lon":110},40.44062,-79.99589,{"facility":112,"city":113,"state":114,"zip":115,"country":116,"geoPoint":117},"Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North","Greater Sudbury","Ontario","P3E 5J1","Canada",{"lat":118,"lon":119},46.49,-80.99001,[],[],[],[],{"nct_id":4,"conditions":125,"biomarkers":127},[126],"Xerostomia",[],{"nct_id":4,"found":43,"summary":42,"prompt_version":42}]