[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588474":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":24,"locations":31,"responsibleParty":161,"collaborators":23,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":165,"sex":171,"minAge":172,"maxAge":23,"enrollmentInfo":173,"targetDuration":23,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":23,"overallStatus":34,"whyStopped":23,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Efanesoctocog Alfa","EXPERIMENTAL","Participants will receive Efanesoctocog Alfa at 50 international unit per kilogram (IU\u002Fkg) intravenous (IV) QW",[13],"Drug: Efanesoctocog alfa",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Efanesoctocog alfa","Pharmaceutical form:Lyophilized powder in a sterile vial that requires reconstitution with sterile water for injection (diluent)-Route of administration:Intravenous",[9],[21,22],"BIVV001","ALTUVIIIO®",null,[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[32,46,56,66,76,88,93,105,114,123,132,143,152],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":23},"Orthopedic Institute for Children- Site Number : 8400009","RECRUITING","Los Angeles","California","90007","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-118.24368,34.05223,{"lat":44,"lon":43},{"facility":47,"status":34,"city":48,"state":49,"zip":50,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":23},"Innovative Hematology, Inc.- Site Number : 8400006","Indianapolis","Indiana","46260",{"type":41,"coordinates":52},[53,54],-86.15804,39.76838,{"lat":54,"lon":53},{"facility":57,"status":34,"city":58,"state":59,"zip":60,"country":38,"countryCode":39,"cosmosGeoPoint":61,"geoPoint":65,"contacts":23},"University of Iowa- Site Number : 8400004","Iowa City","Iowa","52242",{"type":41,"coordinates":62},[63,64],-91.53017,41.66113,{"lat":64,"lon":63},{"facility":67,"status":34,"city":68,"state":69,"zip":70,"country":38,"countryCode":39,"cosmosGeoPoint":71,"geoPoint":75,"contacts":23},"Ohio State University Hospital East- Site Number : 8400001","Columbus","Ohio","43203-1779",{"type":41,"coordinates":72},[73,74],-82.99879,39.96118,{"lat":74,"lon":73},{"facility":77,"status":34,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":23},"Investigational Site Number : 1240003","Hamilton","Ontario","L8N 3Z5","Canada","CA",{"type":41,"coordinates":84},[85,86],-79.84963,43.25011,{"lat":86,"lon":85},{"facility":89,"status":34,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":90,"geoPoint":92,"contacts":23},"Investigational Site Number : 1240004",{"type":41,"coordinates":91},[85,86],{"lat":86,"lon":85},{"facility":94,"status":34,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":23},"Investigational Site Number : 3920003","Kawasaki","Kanagawa","216-8511","Japan","JP",{"type":41,"coordinates":101},[102,103],139.71722,35.52056,{"lat":103,"lon":102},{"facility":106,"status":34,"city":107,"state":23,"zip":108,"country":98,"countryCode":99,"cosmosGeoPoint":109,"geoPoint":113,"contacts":23},"Investigational Site Number : 3920002","Hiroshima","734-8551",{"type":41,"coordinates":110},[111,112],132.45,34.4,{"lat":112,"lon":111},{"facility":115,"status":34,"city":116,"state":23,"zip":117,"country":98,"countryCode":99,"cosmosGeoPoint":118,"geoPoint":122,"contacts":23},"Investigational Site Number : 3920001","Saitama","330-8777",{"type":41,"coordinates":119},[120,121],139.65657,35.90807,{"lat":121,"lon":120},{"facility":124,"status":34,"city":125,"state":23,"zip":126,"country":98,"countryCode":99,"cosmosGeoPoint":127,"geoPoint":131,"contacts":23},"Investigational Site Number : 3920004","Tokyo","160-0023",{"type":41,"coordinates":128},[129,130],139.69171,35.6895,{"lat":130,"lon":129},{"facility":133,"status":34,"city":134,"state":23,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":23},"Investigational Site Number : 1580003","Kaohsiung City","80756","Taiwan","TW",{"type":41,"coordinates":139},[140,141],120.31333,22.61626,{"lat":141,"lon":140},{"facility":144,"status":34,"city":145,"state":23,"zip":146,"country":136,"countryCode":137,"cosmosGeoPoint":147,"geoPoint":151,"contacts":23},"Investigational Site Number : 1580001","Taichung","407",{"type":41,"coordinates":148},[149,150],120.6839,24.1469,{"lat":150,"lon":149},{"facility":153,"status":34,"city":154,"state":23,"zip":155,"country":136,"countryCode":137,"cosmosGeoPoint":156,"geoPoint":160,"contacts":23},"Investigational Site Number : 1580002","Taipei","114",{"type":41,"coordinates":157},[158,159],121.52639,25.05306,{"lat":159,"lon":158},{"type":162,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100588474","phase-4-efanesoctocog-alfa-prophylaxis-in-patients-with-hemophilia-a-with-synovial-hypertrophy-100588474",false,"NCT06941870","Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy","Prospective Interventional Study of Effectiveness of Efanesoctocog Alfa Prophylaxis on Synovial Hypertrophy in Patients With Hemophilia A","SYNOVIIIUS","Inclusion Criteria: Participant is diagnosed with moderate to severe hemophilia A (defined as less than or equal to (≤)5 percent (%) of endogenous FVIII clotting activity) at the time of consent\u002Fassent.\n\nParticipant is more than or equal to (≥)12 years old at the time of consent\u002Fassent.\n\nParticipant has existing synovial hypertrophy, defined as at least 1 eligible\\* joint by the HEAD-US score (Synovitis score: 1 or 2) at the time of consent\u002Fassent.\n\nParticipant has at least 1 eligible\\* joint without planned future major orthopedic procedures (example, arthroscopic synovectomy, radioisotopic or chemical synoviorthesis), or major orthopedic procedures in the past 3 months prior to the screening visit (Visit 1).\n\n\\*An eligible joint is a joint with existing synovial hypertrophy, as defined by a HEAD-US synovitis score of 1 or 2, considering hypertrophic synovium as an indication of the presence of synovitis Participant has received prophylactic treatment with hemophilia prophylaxis prescriptions in the last 12 months prior to the baseline visit (Visit 2).\n\nParticipant is capable of understanding the written Informed Consent Form (ICF)\u002Fassent form, provides a signed and witnessed written ICF\u002Fassent form, and agrees to comply with the protocol requirements.\n\nIf male, no contraceptive measures are required for this study.\n\nIf female, is not pregnant or breastfeeding, and one of the following conditions applies:\n\nIs a women of nonchildbearing potential (WONCBP) Is a women of childbearing potential (WOCBP) and agrees to use a highly effective contraceptive method, with a failure rate of less than (\\\u003C)1 percent during the study treatment period (at least until the Week 52\u002F End of Treatment \\[EoT\\] visit).\n\nA WOCBP must have a negative serum pregnancy test at the screening visit (Visit 1) Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:\n\nHas other associated clotting disorders at the time of consent\u002Fassent. Is already under efanesoctocog alfa treatment. Has a current diagnosis of an factor VIII (FVIII) inhibitor, defined as inhibitor titer ≥0.60 BU\u002FmL.\n\nHas ITI within the last 2 years prior to the baseline visit (Visit 2). Has been enrolled in a concurrent clinical interventional study or exposed to other investigational drug(s) within 3 months prior to screening for this study.\n\nIs currently in an institution because of regulatory or legal order (that is, is a prisoner or a patient who is legally institutionalized).\n\nIs not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.\n\nIs an employee or family member of the investigator or site personnel. Is involved in a specific situation during study implementation or the course of the study that may raise ethics considerations.\n\nHas hypersensitivity to efanesoctocog alfa or its components or any of its excipients that, in the opinion of the investigator, contraindicates participation in the study.","ALL","12 Years",{"count":174,"type":175},35,"ESTIMATED","INTERVENTIONAL",[178],"PHASE4","The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A.\n\nThe study duration for each participant is approximately 12 months.",[181],"Factor VIII Deficiency","2025-11-17",{"date":184,"type":185},"2025-11-18","ACTUAL",{"date":187,"type":185},"2025-09-23",{"date":189,"type":175},"2027-10-25",{"name":5,"class":6},13]