[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569888":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":38,"responsibleParty":219,"collaborators":12,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":223,"sex":228,"minAge":229,"maxAge":12,"enrollmentInfo":230,"targetDuration":12,"studyType":233,"phases":234,"briefSummary":236,"conditions":237,"keywords":12,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},{"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",[39,56,70,84,92,103,117,131,142,153,167,181,198,208],{"facility":40,"status":41,"city":42,"state":12,"zip":12,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Chelyabinsk Regional Clinical Hospital","RECRUITING","Chelyabinsk","Russia","RU",{"type":46,"coordinates":47},"Point",[48,49],61.42877,55.1611,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":12,"email":55},"Alexander Korobkin","+7 (351) 749-37-27","chelokb@mail.ru",{"facility":57,"status":41,"city":58,"state":12,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Federal State Budgetary Organization of Science \"Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency\"","Kirov","610027",{"type":46,"coordinates":61},[62,63],49.65783,58.59809,{"lat":63,"lon":62},[66],{"name":67,"role":34,"phone":68,"phoneExt":12,"email":69},"Margarita Timofeeva","+7 (8332) 25 59 19","niigpk@fmbamail.ru",{"facility":71,"status":41,"city":72,"state":12,"zip":73,"country":43,"countryCode":44,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"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":46,"coordinates":75},[76,77],37.61781,55.75204,{"lat":77,"lon":76},[80],{"name":81,"role":34,"phone":82,"phoneExt":12,"email":83},"Nadezhda Zozulya","+7 (800) 775 05 82","director@blood.ru",{"facility":85,"status":41,"city":72,"state":12,"zip":73,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"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":46,"coordinates":87},[76,77],{"lat":77,"lon":76},[90],{"name":91,"role":34,"phone":82,"phoneExt":12,"email":83},"Vladimir Zorenko",{"facility":93,"status":41,"city":72,"state":12,"zip":94,"country":43,"countryCode":44,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"Federal Budgetary Institution \"Moscow City Clinical Hospital named after S. P. Botkin\"","125284",{"type":46,"coordinates":96},[76,77],{"lat":77,"lon":76},[99],{"name":100,"role":34,"phone":101,"phoneExt":12,"email":102},"Vadim Ptushkin","+7 (499) 490 03 03","glavbotkin@zdrav.mos.ru",{"facility":104,"status":41,"city":105,"state":12,"zip":106,"country":43,"countryCode":44,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"State Novosibirsk Regional Clinical Hospital","Novosibirsk","630087",{"type":46,"coordinates":108},[109,110],82.93175,55.02259,{"lat":110,"lon":109},[113],{"name":114,"role":34,"phone":115,"phoneExt":12,"email":116},"Tatyana Pospelova","+7 (383) 315 99 99","gnokb@oblmed.nsk.ru",{"facility":118,"status":41,"city":119,"state":12,"zip":120,"country":43,"countryCode":44,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"State budgetary healthcare institution Leningrad Regional Clinical Hospital","Saint Petersburg","188663",{"type":46,"coordinates":122},[123,124],30.31413,59.93863,{"lat":124,"lon":123},[127],{"name":128,"role":34,"phone":129,"phoneExt":12,"email":130},"Sergey Voloshin","+7 (812) 670 18 88","lokb@47lokb.ru",{"facility":132,"status":41,"city":119,"state":12,"zip":133,"country":43,"countryCode":44,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency","193024",{"type":46,"coordinates":135},[123,124],{"lat":124,"lon":123},[138],{"name":139,"role":34,"phone":140,"phoneExt":12,"email":141},"Andrey Garifullin","+7 (812) 309 79 81","bloodscience@mail.ru",{"facility":143,"status":41,"city":119,"state":12,"zip":144,"country":43,"countryCode":44,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Almazov National Medical Research Centre","197341",{"type":46,"coordinates":146},[123,124],{"lat":124,"lon":123},[149],{"name":150,"role":34,"phone":151,"phoneExt":12,"email":152},"Vladimir Ivanov","+7 (812) 702 37 16","pmu@almazovcentre.ru",{"facility":154,"status":41,"city":155,"state":12,"zip":156,"country":43,"countryCode":44,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Federal State Budgetary Educational Institution of Higher Education \"Samara State Medical University\" of the Ministry of Healthcare of the Russian Federation","Samara","443099",{"type":46,"coordinates":158},[159,160],50.13553,53.20767,{"lat":160,"lon":159},[163],{"name":164,"role":34,"phone":165,"phoneExt":12,"email":166},"Igor Davydkin","+7 (846) 374 91 00","info@samsmu.ru",{"facility":168,"status":41,"city":169,"state":12,"zip":170,"country":43,"countryCode":44,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Federal State Budgetary Educational Institution of Higher Education \"Bashkir State Medical University\" of the Ministry of Healthcare of the Russian Federation","Ufa","450008",{"type":46,"coordinates":172},[173,174],55.96779,54.74306,{"lat":174,"lon":173},[177],{"name":178,"role":34,"phone":179,"phoneExt":12,"email":180},"Bulat Bakhirov","+7 (347) 272 41 73","bashsmu@yandex.ru",{"facility":182,"status":183,"city":184,"state":12,"zip":185,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"King Chulalongkorn Memorial Hospital","NOT_YET_RECRUITING","Bangkok","10330","Thailand","TH",{"type":46,"coordinates":189},[190,191],100.50144,13.75398,{"lat":191,"lon":190},[194],{"name":195,"role":34,"phone":196,"phoneExt":12,"email":197},"Ponlapat Rojnuckarin","6685-911-521","ponlapat.r@chula.ac.th",{"facility":199,"status":183,"city":184,"state":12,"zip":200,"country":186,"countryCode":187,"cosmosGeoPoint":201,"geoPoint":203,"contacts":204},"Ramathibodi Hospital","10400",{"type":46,"coordinates":202},[190,191],{"lat":191,"lon":190},[205],{"name":206,"role":34,"phone":12,"phoneExt":12,"email":207},"Pantep Angchaisuksiri","pantep.ang@mahidol.ac.th",{"facility":209,"status":183,"city":184,"state":12,"zip":210,"country":186,"countryCode":187,"cosmosGeoPoint":211,"geoPoint":213,"contacts":214},"Siriraj Hospital","10700",{"type":46,"coordinates":212},[190,191],{"lat":191,"lon":190},[215],{"name":216,"role":34,"phone":217,"phoneExt":12,"email":218},"Yingyong Chinnathammamit","6681-426-4252","dryingyong@gmail.com",{"type":220,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100569888","phase-3-an-open-label-comparative-study-of-the-efficacy-safety-and-pharmacodynamics-of-single-dose-of-anb-002-in-patients-with-hemophilia-b-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":231,"type":232},24,"ESTIMATED","INTERVENTIONAL",[235],"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.",[238],"Hemophilia B","2025-11-17",{"date":241,"type":242},"2025-11-18","ACTUAL",{"date":244,"type":242},"2024-11-07",{"date":246,"type":232},"2032-03",{"name":5,"class":6},14]