[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569888":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":38,"responsibleParty":217,"collaborators":12,"id":219,"slug":12,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":220,"sex":225,"minAge":226,"maxAge":12,"enrollmentInfo":227,"targetDuration":12,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":12,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"Biocad","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Lead-in","NO_INTERVENTION","All subjects will be enrolled in the Lead-in period in order to collect information on individual bleeding rate anf FIX concentrates consumption",null,{"label":14,"type":15,"description":16,"interventionNames":17},"ANB-002 (arvenacogene sanparvovec)","EXPERIMENTAL","After completion of lead-in period subjects will enter the main period which starts with ANB-002 (arvenacogene sanparvovec) infusion.",[18],"Genetic: ANB-002",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"GENETIC","ANB-002","Adeno-associated viral vector carrying the FIX gene single infusion",[14],[26],"arvenacogene sanparvovec",[28],{"name":29,"affiliation":5,"role":30},"Arina Arina V Zinkina-Orikhan","STUDY_DIRECTOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Anna Eremeeva, MD PhD","CONTACT","+7 (812) 380 49 34","6963","eremeevaav@biocad.ru",[39,55,69,83,91,102,116,130,141,152,166,180,196,206],{"facility":40,"status":41,"city":42,"state":12,"zip":12,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Chelyabinsk Regional Clinical Hospital","RECRUITING","Chelyabinsk","Russia",{"type":45,"coordinates":46},"Point",[47,48],61.42877,55.1611,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":53,"phoneExt":12,"email":54},"Alexander Korobkin","+7 (351) 749-37-27","chelokb@mail.ru",{"facility":56,"status":41,"city":57,"state":12,"zip":58,"country":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Federal State Budgetary Organization of Science \"Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency\"","Kirov","610027",{"type":45,"coordinates":60},[61,62],49.65783,58.59809,{"lat":62,"lon":61},[65],{"name":66,"role":34,"phone":67,"phoneExt":12,"email":68},"Margarita Timofeeva","+7 (8332) 25 59 19","niigpk@fmbamail.ru",{"facility":70,"status":41,"city":71,"state":12,"zip":72,"country":43,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Federal State Budgetary Institution \"National Medical Research Centre for Hematology\" of the Ministry of Health of Russian Federation (Department of Clinical Diagnostics for Hematology and Hemostasis Disorders)","Moscow","125167",{"type":45,"coordinates":74},[75,76],37.61781,55.75204,{"lat":76,"lon":75},[79],{"name":80,"role":34,"phone":81,"phoneExt":12,"email":82},"Nadezhda Zozulya","+7 (800) 775 05 82","director@blood.ru",{"facility":84,"status":41,"city":71,"state":12,"zip":72,"country":43,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Federal State Budgetary Institution \"National Medical Research Centre for Hematology\" of the Ministry of Health of Russian Federation (Department of Traumatology and Reconstructive and Restorative Orthopedics for Patients with Hemophilia)",{"type":45,"coordinates":86},[75,76],{"lat":76,"lon":75},[89],{"name":90,"role":34,"phone":81,"phoneExt":12,"email":82},"Vladimir Zorenko",{"facility":92,"status":41,"city":71,"state":12,"zip":93,"country":43,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Federal Budgetary Institution \"Moscow City Clinical Hospital named after S. P. Botkin\"","125284",{"type":45,"coordinates":95},[75,76],{"lat":76,"lon":75},[98],{"name":99,"role":34,"phone":100,"phoneExt":12,"email":101},"Vadim Ptushkin","+7 (499) 490 03 03","glavbotkin@zdrav.mos.ru",{"facility":103,"status":41,"city":104,"state":12,"zip":105,"country":43,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"State Novosibirsk Regional Clinical Hospital","Novosibirsk","630087",{"type":45,"coordinates":107},[108,109],82.93175,55.02259,{"lat":109,"lon":108},[112],{"name":113,"role":34,"phone":114,"phoneExt":12,"email":115},"Tatyana Pospelova","+7 (383) 315 99 99","gnokb@oblmed.nsk.ru",{"facility":117,"status":41,"city":118,"state":12,"zip":119,"country":43,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"State budgetary healthcare institution Leningrad Regional Clinical Hospital","Saint Petersburg","188663",{"type":45,"coordinates":121},[122,123],30.31413,59.93863,{"lat":123,"lon":122},[126],{"name":127,"role":34,"phone":128,"phoneExt":12,"email":129},"Sergey Voloshin","+7 (812) 670 18 88","lokb@47lokb.ru",{"facility":131,"status":41,"city":118,"state":12,"zip":132,"country":43,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency","193024",{"type":45,"coordinates":134},[122,123],{"lat":123,"lon":122},[137],{"name":138,"role":34,"phone":139,"phoneExt":12,"email":140},"Andrey Garifullin","+7 (812) 309 79 81","bloodscience@mail.ru",{"facility":142,"status":41,"city":118,"state":12,"zip":143,"country":43,"cosmosGeoPoint":144,"geoPoint":146,"contacts":147},"Almazov National Medical Research Centre","197341",{"type":45,"coordinates":145},[122,123],{"lat":123,"lon":122},[148],{"name":149,"role":34,"phone":150,"phoneExt":12,"email":151},"Vladimir Ivanov","+7 (812) 702 37 16","pmu@almazovcentre.ru",{"facility":153,"status":41,"city":154,"state":12,"zip":155,"country":43,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Federal State Budgetary Educational Institution of Higher Education \"Samara State Medical University\" of the Ministry of Healthcare of the Russian Federation","Samara","443099",{"type":45,"coordinates":157},[158,159],50.13553,53.20767,{"lat":159,"lon":158},[162],{"name":163,"role":34,"phone":164,"phoneExt":12,"email":165},"Igor Davydkin","+7 (846) 374 91 00","info@samsmu.ru",{"facility":167,"status":41,"city":168,"state":12,"zip":169,"country":43,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Federal State Budgetary Educational Institution of Higher Education \"Bashkir State Medical University\" of the Ministry of Healthcare of the Russian Federation","Ufa","450008",{"type":45,"coordinates":171},[172,173],55.96779,54.74306,{"lat":173,"lon":172},[176],{"name":177,"role":34,"phone":178,"phoneExt":12,"email":179},"Bulat Bakhirov","+7 (347) 272 41 73","bashsmu@yandex.ru",{"facility":181,"status":182,"city":183,"state":12,"zip":184,"country":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"King Chulalongkorn Memorial Hospital","NOT_YET_RECRUITING","Bangkok","10330","Thailand",{"type":45,"coordinates":187},[188,189],100.50144,13.75398,{"lat":189,"lon":188},[192],{"name":193,"role":34,"phone":194,"phoneExt":12,"email":195},"Ponlapat Rojnuckarin","6685-911-521","ponlapat.r@chula.ac.th",{"facility":197,"status":182,"city":183,"state":12,"zip":198,"country":185,"cosmosGeoPoint":199,"geoPoint":201,"contacts":202},"Ramathibodi Hospital","10400",{"type":45,"coordinates":200},[188,189],{"lat":189,"lon":188},[203],{"name":204,"role":34,"phone":12,"phoneExt":12,"email":205},"Pantep Angchaisuksiri","pantep.ang@mahidol.ac.th",{"facility":207,"status":182,"city":183,"state":12,"zip":208,"country":185,"cosmosGeoPoint":209,"geoPoint":211,"contacts":212},"Siriraj Hospital","10700",{"type":45,"coordinates":210},[188,189],{"lat":189,"lon":188},[213],{"name":214,"role":34,"phone":215,"phoneExt":12,"email":216},"Yingyong Chinnathammamit","6681-426-4252","dryingyong@gmail.com",{"type":218,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100569888",false,"NCT06700096","An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B","MAGNOLIA","Inclusion Criteria:\n\n* Men diagnosed with hemophilia B aged 18 or older\n* FIX activity ≤2%\n* Absense of FIX inhibitor\n* ≥150 previous exposure days of treatment with FIX concentrates\n\nExclusion Criteria:\n\n* Any diseases of blood and hematopoietic organs other than hemophilia B\n* A history of any gene therapy, including ANB-002\n* Diagnosed HIV-infection, not controlled with anti-viral therapy\n* Active HBV or HCV infection\n* Anti-AAV5 antibodies\n* Any active systemic infections or recurrent infections requiring systemic therapy\n* Any other disorders associated with severe immunodeficiency\n* Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder\n* Malignancies with less than 5 years of remission","MALE","18 Years",{"count":228,"type":229},24,"ESTIMATED","INTERVENTIONAL",[232],"PHASE3","The aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.",[235],"Hemophilia B","2025-11-17",{"date":238,"type":239},"2025-11-18","ACTUAL",{"date":241,"type":239},"2024-11-07",{"date":243,"type":229},"2032-03",{"name":5,"class":6},14]