[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610158":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":27,"overallOfficials":13,"centralContacts":32,"locations":38,"responsibleParty":472,"collaborators":13,"id":474,"slug":475,"hasResults":476,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":476,"sex":482,"minAge":483,"maxAge":13,"enrollmentInfo":484,"targetDuration":13,"studyType":487,"phases":488,"briefSummary":490,"conditions":491,"keywords":13,"overallStatus":41,"whyStopped":13,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},{"fullName":5,"class":6},"Spur Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the efficacy of FLT201","Proportion of participants with stable hemoglobin concentration (decrease from baseline of no more than 1.5 g\u002FdL) at Week 52","1 Year",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":24,"interventionNames":25},"FLT201","EXPERIMENTAL","FLT201 is an advanced therapy investigational medicinal product (ATIMP) administered as a single intravenous infusion",[26],"Genetic: FLT201",[28],{"type":29,"name":22,"description":30,"armGroupLabels":31,"otherNames":13},"GENETIC","FLT201 is a replication-incompetent single-stranded (ss) recombinant adeno-associated virus (AAV) vector. The vector is composed of a ss DNA genome packaged in an AAV-derived protein capsid.",[22],[33],{"name":34,"role":35,"phone":36,"phoneExt":13,"email":37},"Spur Clinical Trials Contact","CONTACT","+44 (0)1438 906870","clinicaltrials@spurtherapeutics.com",[39,58,69,84,99,114,130,148,163,177,187,202,217,232,246,264,282,293,299,308,315,326,343,353,368,381,392,403,417,428,439,449,463],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Kaiser Permanente - CA","RECRUITING","Los Angeles","California","90027","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-118.24368,34.05223,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":13,"email":57},"Dr. Divya Vats","626-646-4612","divya.vats@kp.org",{"facility":59,"status":41,"city":42,"state":43,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"UCLA Health","90095",{"type":48,"coordinates":62},[50,51],{"lat":51,"lon":50},[65],{"name":66,"role":35,"phone":67,"phoneExt":13,"email":68},"Dr. Nicola Longo","310-825-5610","wsia@mednet.ucla.edu",{"facility":70,"status":41,"city":71,"state":43,"zip":72,"country":45,"countryCode":46,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University of California, San Francisco (UCSF)","San Francisco","94609",{"type":48,"coordinates":74},[75,76],-122.41942,37.77493,{"lat":76,"lon":75},[79],{"name":80,"role":35,"phone":81,"phoneExt":82,"email":83},"Dr. Irene Chang","510-428-3885","7217","Irene.chang@ucsf.edu",{"facility":85,"status":41,"city":86,"state":87,"zip":88,"country":45,"countryCode":46,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University of Colorado Anschutz","Aurora","Colorado","80045",{"type":48,"coordinates":90},[91,92],-104.83192,39.72943,{"lat":92,"lon":91},[95],{"name":96,"role":35,"phone":97,"phoneExt":13,"email":98},"Dr. Matthew Taylor","720-446-6680","matthew.taylor@CUAnschutz.edu",{"facility":100,"status":41,"city":101,"state":102,"zip":103,"country":45,"countryCode":46,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Emory Healthcare","Atlanta","Georgia","30322",{"type":48,"coordinates":105},[106,107],-84.38798,33.749,{"lat":107,"lon":106},[110],{"name":111,"role":35,"phone":112,"phoneExt":13,"email":113},"Dr. William Wilcox","404-778-8618","william.wilcox@emory.edu",{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":45,"countryCode":46,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"University of Iowa Health Care","NOT_YET_RECRUITING","Iowa City","Iowa","52242",{"type":48,"coordinates":121},[122,123],-91.53017,41.66113,{"lat":123,"lon":122},[126],{"name":127,"role":35,"phone":128,"phoneExt":13,"email":129},"Dr. John Bernat","319-356-2675","john-bernat@uiowa.edu",{"facility":131,"status":41,"city":132,"state":133,"zip":134,"country":45,"countryCode":46,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"University of Minnesota","Minneapolis","Minnesota","55454",{"type":48,"coordinates":136},[137,138],-93.26384,44.97997,{"lat":138,"lon":137},[141,145],{"name":142,"role":35,"phone":143,"phoneExt":13,"email":144},"Dr. Whitley","612-625-1594","whitley@umn.edu",{"name":146,"role":35,"phone":13,"phoneExt":13,"email":147},"Brenda Diethelm-Okita","dieth001@umn.edu",{"facility":149,"status":116,"city":150,"state":151,"zip":152,"country":45,"countryCode":46,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":48,"coordinates":154},[155,156],-74.04347,40.88593,{"lat":156,"lon":155},[159],{"name":160,"role":35,"phone":161,"phoneExt":13,"email":162},"Dr. Helio Pedro","551-996-8178","helio.pedro@hmhn.org",{"facility":164,"status":41,"city":165,"state":165,"zip":166,"country":45,"countryCode":46,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"NYU Langone Health","New York","10017",{"type":48,"coordinates":168},[169,170],-74.00597,40.71427,{"lat":170,"lon":169},[173],{"name":174,"role":35,"phone":175,"phoneExt":13,"email":176},"Dr. Nicolas Abreu","929-455-5629","Neurogenetics@nyulangone.org",{"facility":178,"status":116,"city":165,"state":165,"zip":179,"country":45,"countryCode":46,"cosmosGeoPoint":180,"geoPoint":182,"contacts":183},"Columbia University","10032",{"type":48,"coordinates":181},[169,170],{"lat":170,"lon":169},[184],{"name":13,"role":35,"phone":185,"phoneExt":13,"email":186},"212-342-3647","gm3025@cumc.columbia.edu",{"facility":188,"status":41,"city":189,"state":190,"zip":191,"country":45,"countryCode":46,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Duke University Medical Center","Durham","North Carolina","27710",{"type":48,"coordinates":193},[194,195],-78.89862,35.99403,{"lat":195,"lon":194},[198],{"name":199,"role":35,"phone":200,"phoneExt":13,"email":201},"Dr. Priya Kishnani","919-215-0097","priya.kishnani@duke.edu",{"facility":203,"status":116,"city":204,"state":205,"zip":206,"country":45,"countryCode":46,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":48,"coordinates":208},[209,210],-84.51439,39.12711,{"lat":210,"lon":209},[213],{"name":214,"role":35,"phone":215,"phoneExt":13,"email":216},"Dr. Robert Hopkin","513-636-4760","leanne.hagen@cchmc.org",{"facility":218,"status":41,"city":219,"state":220,"zip":221,"country":45,"countryCode":46,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":48,"coordinates":223},[224,225],-75.16362,39.95238,{"lat":225,"lon":224},[228],{"name":229,"role":35,"phone":230,"phoneExt":13,"email":231},"Dr. Can Ficicioglu","215-590-3376","FICICIOGLU@chop.edu",{"facility":233,"status":41,"city":234,"state":220,"zip":235,"country":45,"countryCode":46,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","15224",{"type":48,"coordinates":237},[238,239],-79.99589,40.44062,{"lat":239,"lon":238},[242],{"name":243,"role":35,"phone":244,"phoneExt":13,"email":245},"Dr. Damara Ortiz","412-692-3475","Nadene.Henderson@chp.edu",{"facility":247,"status":41,"city":248,"state":249,"zip":250,"country":45,"countryCode":46,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"University of Texas Southwestern","Dallas","Texas","75390",{"type":48,"coordinates":252},[253,254],-96.80667,32.78306,{"lat":254,"lon":253},[257,261],{"name":258,"role":35,"phone":259,"phoneExt":13,"email":260},"Dr. Markey McNutt","214-648-1222","geneticsresearch@utsouthwestern.edu",{"name":262,"role":35,"phone":13,"phoneExt":13,"email":263},"Jordan Roberts","jordan.roberts2@UTSouthwestern.edu",{"facility":265,"status":41,"city":266,"state":267,"zip":268,"country":45,"countryCode":46,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Lysosomal Rare Disorders Research and Treatment Center","Fairfax","Virginia","22030-6066",{"type":48,"coordinates":270},[271,272],-77.30637,38.84622,{"lat":272,"lon":271},[275,279],{"name":276,"role":35,"phone":277,"phoneExt":13,"email":278},"Lauren Noll","(703) 2616220","lnoll@ldrtc.org",{"name":280,"role":35,"phone":277,"phoneExt":13,"email":281},"Ozlem Goker-Alpan","ogoker-alpan@ldrtc.org",{"facility":283,"status":41,"city":284,"state":13,"zip":285,"country":286,"countryCode":287,"cosmosGeoPoint":288,"geoPoint":292,"contacts":13},"Hospital Italiano de Buenos Aires","Buenos Aires","C1199ABB","Argentina","AR",{"type":48,"coordinates":289},[290,291],-58.37723,-34.61315,{"lat":291,"lon":290},{"facility":294,"status":41,"city":284,"state":13,"zip":295,"country":286,"countryCode":287,"cosmosGeoPoint":296,"geoPoint":298,"contacts":13},"Hospital Militar Central","C1426BOR",{"type":48,"coordinates":297},[290,291],{"lat":291,"lon":290},{"facility":300,"status":41,"city":301,"state":13,"zip":302,"country":286,"countryCode":287,"cosmosGeoPoint":303,"geoPoint":307,"contacts":13},"Clinica Universitaria Reina Fabiola","Córdoba","X5004ASL",{"type":48,"coordinates":304},[305,306],-64.18853,-31.40648,{"lat":306,"lon":305},{"facility":309,"status":116,"city":310,"state":311,"zip":312,"country":313,"countryCode":314,"cosmosGeoPoint":13,"geoPoint":13,"contacts":13},"Melbourne Health - Royal Melbourne Hospital","Melbourne N.","Victoria","3051","Australia","AU",{"facility":316,"status":41,"city":317,"state":13,"zip":318,"country":319,"countryCode":320,"cosmosGeoPoint":321,"geoPoint":325,"contacts":13},"Hospital de Clinicas de Porto Alegre","Porto Alegre","90035-903","Brazil","BR",{"type":48,"coordinates":322},[323,324],-51.23019,-30.03283,{"lat":324,"lon":323},{"facility":327,"status":41,"city":328,"state":329,"zip":330,"country":331,"countryCode":332,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"MAGIC Clinic Ltd","Calgary","Alberta","T2E 7H7","Canada","CA",{"type":48,"coordinates":334},[335,336],-114.08529,51.05011,{"lat":336,"lon":335},[339],{"name":340,"role":35,"phone":341,"phoneExt":13,"email":342},"Dr. Aneal Khan","587-885-3158","research@magiccalgary.ca",{"facility":344,"status":41,"city":345,"state":346,"zip":347,"country":331,"countryCode":332,"cosmosGeoPoint":348,"geoPoint":352,"contacts":13},"Lady Davis Institute for Medical Research Jewish General Hospital","Montreal","Quebec","T2E 7Z4",{"type":48,"coordinates":349},[350,351],-73.58781,45.50884,{"lat":351,"lon":350},{"facility":354,"status":41,"city":355,"state":13,"zip":13,"country":356,"countryCode":357,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"Shaare Zedek Medical Center","Jerusalem","Israel","IL",{"type":48,"coordinates":359},[360,361],35.21633,31.76904,{"lat":361,"lon":360},[364],{"name":365,"role":35,"phone":366,"phoneExt":13,"email":367},"Dr. Revel-Vilk","+972-2-6555143","srevelvilk@gmail.com",{"facility":369,"status":41,"city":370,"state":13,"zip":13,"country":356,"countryCode":357,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Rabin Medical Center, Beilinson Hospital","Petah Tikva",{"type":48,"coordinates":372},[373,374],34.88747,32.08707,{"lat":374,"lon":373},[377],{"name":378,"role":35,"phone":379,"phoneExt":13,"email":380},"Dr. Ruhrman Shahar","+972-3-6974905","noa.ruhrman@clalit.org.il",{"facility":382,"status":116,"city":383,"state":13,"zip":384,"country":385,"countryCode":386,"cosmosGeoPoint":387,"geoPoint":391,"contacts":13},"King Faisal Specialist Hospital and Research Center","Riyadh","12713","Saudi Arabia","SA",{"type":48,"coordinates":388},[389,390],46.72185,24.68773,{"lat":390,"lon":389},{"facility":393,"status":116,"city":394,"state":394,"zip":395,"country":396,"countryCode":397,"cosmosGeoPoint":398,"geoPoint":402,"contacts":13},"Hospital Universitario Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":48,"coordinates":399},[400,401],2.15899,41.38879,{"lat":401,"lon":400},{"facility":404,"status":116,"city":405,"state":13,"zip":406,"country":396,"countryCode":397,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"Hospital Quironsalud de Zaragoza","Zaragoza","50012",{"type":48,"coordinates":408},[409,410],-0.87734,41.65606,{"lat":410,"lon":409},[413],{"name":414,"role":35,"phone":415,"phoneExt":13,"email":416},"Dr. P. Giraldo","0034976 72 00 00","giraldocastellano@gmail.com",{"facility":418,"status":116,"city":419,"state":420,"zip":421,"country":422,"countryCode":13,"cosmosGeoPoint":423,"geoPoint":427,"contacts":13},"Gazi University Medical Faculty","Ankara","Yenimahalle","06560","Turkey (Türkiye)",{"type":48,"coordinates":424},[425,426],32.85427,39.91987,{"lat":426,"lon":425},{"facility":429,"status":116,"city":430,"state":430,"zip":431,"country":432,"countryCode":433,"cosmosGeoPoint":434,"geoPoint":438,"contacts":13},"Queen Elizabeth Hospital Birmingham","Birmingham","B15 2GW","United Kingdom","UK",{"type":48,"coordinates":435},[436,437],-1.89983,52.48142,{"lat":437,"lon":436},{"facility":440,"status":116,"city":441,"state":442,"zip":443,"country":432,"countryCode":433,"cosmosGeoPoint":444,"geoPoint":448,"contacts":13},"Salford Royal Hospital","Salford","Greater Manchester","M6 8HD",{"type":48,"coordinates":445},[446,447],-2.29042,53.48771,{"lat":447,"lon":446},{"facility":450,"status":41,"city":451,"state":451,"zip":452,"country":432,"countryCode":433,"cosmosGeoPoint":453,"geoPoint":457,"contacts":458},"Royal Free Hospital","London","NW3 2QG",{"type":48,"coordinates":454},[455,456],-0.12574,51.50853,{"lat":456,"lon":455},[459],{"name":460,"role":35,"phone":461,"phoneExt":13,"email":462},"Dr. Derralynn Hughes","+44-2077940500","derralynnhughes@nhs.net",{"facility":464,"status":116,"city":465,"state":13,"zip":466,"country":432,"countryCode":433,"cosmosGeoPoint":467,"geoPoint":471,"contacts":13},"Addenbrooke's Hospital","Cambridge","CB2 0QQ",{"type":48,"coordinates":468},[469,470],0.11667,52.2,{"lat":470,"lon":469},{"type":473,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100610158","phase-3-a-gaucher-disease-gene-therapy-trial-with-flt201-100610158",false,"NCT07223944","A Gaucher Disease Gene Therapy Trial With FLT201","A Phase 3 Safety and Efficacy Trial of FLT201 Gene Therapy in Patients With Gaucher Disease Type 1","GALILEO-3","Key Inclusion Criteria:\n\n* Aged ≥18 years at time of screening.\n* Clinical diagnosis of Gaucher disease type 1\n* Stable hemoglobin concentration at baseline\n* Stable platelet count at baseline\n* Receiving ERT or SRT without interruption for at least 2 years\n\nKey Exclusion Criteria:\n\n* Diagnosed or suspected Gaucher disease type 2 or type 3\n* Positive for AAVS3 neutralizing antibodies.\n* Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study\n* Positive pregnancy test or lactating\n* History of hematopoietic stem cell transplant (HSCT)\u002Fbone marrow transplant or any solid organ transplant.\n* History of receiving any gene therapy or cell therapy.\n* History of total splenectomy. Note: Additional protocol defined Inclusion and Exclusion criteria apply","ALL","18 Years",{"count":485,"type":486},45,"ESTIMATED","INTERVENTIONAL",[489],"PHASE3","This study is a Phase 3, non-randomized, multicenter, efficacy and safety study in adult patients with Gaucher disease Type 1, on stable treatment with enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 2 years. The study aims to confirm the efficacy and safety of FLT201 in this population after discontinuation of ERT\u002FSRT.",[492],"Gaucher Disease Type 1","2026-09-02",{"date":495,"type":496},"2026-09-03","ACTUAL",{"date":498,"type":496},"2026-04-07",{"date":500,"type":486},"2032-10-01",{"name":5,"class":6},33]