[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399182":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":11,"locations":26,"responsibleParty":239,"collaborators":11,"id":241,"slug":242,"hasResults":243,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":11,"eligibilityCriteria":247,"healthyVolunteers":243,"sex":248,"minAge":249,"maxAge":11,"enrollmentInfo":250,"targetDuration":11,"studyType":253,"phases":254,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":262,"whyStopped":11,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},{"fullName":5,"class":6},"Celgene","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Luspatercept Administration","EXPERIMENTAL",null,[13],"Drug: Luspatercept",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Luspatercept","Specified dose on specified days",[9],[21],"ACE-536",[23],{"name":24,"affiliation":24,"role":25},"Bristol-Myers Squibb","STUDY_DIRECTOR",[27,39,43,52,58,64,73,82,91,100,106,115,124,133,142,154,163,173,182,191,195,203,212,221,230],{"facility":28,"status":11,"city":29,"state":11,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":11},"Local Institution - 100","Beijing","100730","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},{"facility":40,"status":11,"city":41,"state":11,"zip":42,"country":31,"countryCode":32,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Local Institution - 107","Chengdu, Sichuan","610041",{"facility":44,"status":11,"city":45,"state":11,"zip":46,"country":31,"countryCode":32,"cosmosGeoPoint":47,"geoPoint":51,"contacts":11},"Local Institution - 105","Guangzhou","510060",{"type":34,"coordinates":48},[49,50],113.25,23.11667,{"lat":50,"lon":49},{"facility":53,"status":11,"city":45,"state":11,"zip":54,"country":31,"countryCode":32,"cosmosGeoPoint":55,"geoPoint":57,"contacts":11},"Local Institution - 103","510080",{"type":34,"coordinates":56},[49,50],{"lat":50,"lon":49},{"facility":59,"status":11,"city":45,"state":11,"zip":60,"country":31,"countryCode":32,"cosmosGeoPoint":61,"geoPoint":63,"contacts":11},"Local Institution - 109","510515",{"type":34,"coordinates":62},[49,50],{"lat":50,"lon":49},{"facility":65,"status":11,"city":66,"state":11,"zip":67,"country":31,"countryCode":32,"cosmosGeoPoint":68,"geoPoint":72,"contacts":11},"Local Institution - 102","Hangzhou","310006",{"type":34,"coordinates":69},[70,71],120.16142,30.29365,{"lat":71,"lon":70},{"facility":74,"status":11,"city":75,"state":11,"zip":76,"country":31,"countryCode":32,"cosmosGeoPoint":77,"geoPoint":81,"contacts":11},"Local Institution - 112","Nanchang","330006",{"type":34,"coordinates":78},[79,80],115.85306,28.68396,{"lat":80,"lon":79},{"facility":83,"status":11,"city":84,"state":11,"zip":85,"country":31,"countryCode":32,"cosmosGeoPoint":86,"geoPoint":90,"contacts":11},"Local Institution - 108","Nanjing","210029",{"type":34,"coordinates":87},[88,89],118.77778,32.06167,{"lat":89,"lon":88},{"facility":92,"status":11,"city":93,"state":11,"zip":94,"country":31,"countryCode":32,"cosmosGeoPoint":95,"geoPoint":99,"contacts":11},"Local Institution - 114","Shanghai","0",{"type":34,"coordinates":96},[97,98],121.45806,31.22222,{"lat":98,"lon":97},{"facility":101,"status":11,"city":93,"state":11,"zip":102,"country":31,"countryCode":32,"cosmosGeoPoint":103,"geoPoint":105,"contacts":11},"Local Institution - 101","200233",{"type":34,"coordinates":104},[97,98],{"lat":98,"lon":97},{"facility":107,"status":11,"city":108,"state":11,"zip":109,"country":31,"countryCode":32,"cosmosGeoPoint":110,"geoPoint":114,"contacts":11},"Local Institution - 104","Suzhu","215006",{"type":34,"coordinates":111},[112,113],103.103,24.7437,{"lat":113,"lon":112},{"facility":116,"status":11,"city":117,"state":11,"zip":118,"country":31,"countryCode":32,"cosmosGeoPoint":119,"geoPoint":123,"contacts":11},"Local Institution - 106","Tianjin","300020",{"type":34,"coordinates":120},[121,122],117.17667,39.14222,{"lat":122,"lon":121},{"facility":125,"status":11,"city":126,"state":11,"zip":127,"country":31,"countryCode":32,"cosmosGeoPoint":128,"geoPoint":132,"contacts":11},"Local Institution - 111","Wenzhou","325000",{"type":34,"coordinates":129},[130,131],120.66682,27.99942,{"lat":131,"lon":130},{"facility":134,"status":11,"city":135,"state":11,"zip":136,"country":31,"countryCode":32,"cosmosGeoPoint":137,"geoPoint":141,"contacts":11},"Local Institution - 110","Wuhan","430022",{"type":34,"coordinates":138},[139,140],114.26667,30.58333,{"lat":140,"lon":139},{"facility":143,"status":11,"city":144,"state":145,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":11},"Local Institution - 209","Matsuyama","Ehime","790-8524","Japan","JP",{"type":34,"coordinates":150},[151,152],132.76574,33.83916,{"lat":152,"lon":151},{"facility":155,"status":11,"city":156,"state":156,"zip":157,"country":147,"countryCode":148,"cosmosGeoPoint":158,"geoPoint":162,"contacts":11},"Local Institution - 203","Nagasaki","8528511",{"type":34,"coordinates":159},[160,161],129.88333,32.75,{"lat":161,"lon":160},{"facility":164,"status":11,"city":165,"state":166,"zip":167,"country":147,"countryCode":148,"cosmosGeoPoint":168,"geoPoint":172,"contacts":11},"Local Institution - 210","Sayama","Osaka","5898511",{"type":34,"coordinates":169},[170,171],135.56298,34.51685,{"lat":171,"lon":170},{"facility":174,"status":11,"city":175,"state":11,"zip":176,"country":147,"countryCode":148,"cosmosGeoPoint":177,"geoPoint":181,"contacts":11},"Local Institution - UNK11","Fukuoka","810-8563",{"type":34,"coordinates":178},[179,180],130.41667,33.6,{"lat":180,"lon":179},{"facility":183,"status":11,"city":184,"state":11,"zip":185,"country":147,"countryCode":148,"cosmosGeoPoint":186,"geoPoint":190,"contacts":11},"Local Institution - 206","Kamogawa","296-8602",{"type":34,"coordinates":187},[188,189],140.1003,35.0969,{"lat":189,"lon":188},{"facility":192,"status":11,"city":193,"state":11,"zip":194,"country":147,"countryCode":148,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Local Institution - 201","Mibu-Machi","321-0293",{"facility":196,"status":11,"city":166,"state":11,"zip":197,"country":147,"countryCode":148,"cosmosGeoPoint":198,"geoPoint":202,"contacts":11},"Local Institution - 205","545-8585",{"type":34,"coordinates":199},[200,201],135.50107,34.69379,{"lat":201,"lon":200},{"facility":204,"status":11,"city":205,"state":11,"zip":206,"country":147,"countryCode":148,"cosmosGeoPoint":207,"geoPoint":211,"contacts":11},"Local Institution - 208","Ōgaki","503-8502",{"type":34,"coordinates":208},[209,210],136.61667,35.35,{"lat":210,"lon":209},{"facility":213,"status":11,"city":214,"state":11,"zip":215,"country":147,"countryCode":148,"cosmosGeoPoint":216,"geoPoint":220,"contacts":11},"Local Institution - 204","Sagamihara","252-0375",{"type":34,"coordinates":217},[218,219],139.24167,35.56707,{"lat":219,"lon":218},{"facility":222,"status":11,"city":223,"state":11,"zip":224,"country":147,"countryCode":148,"cosmosGeoPoint":225,"geoPoint":229,"contacts":11},"Local Institution - 207","Sendai","980-8574",{"type":34,"coordinates":226},[227,228],140.86667,38.26667,{"lat":228,"lon":227},{"facility":231,"status":11,"city":232,"state":11,"zip":233,"country":147,"countryCode":148,"cosmosGeoPoint":234,"geoPoint":238,"contacts":11},"Local Institution - 202","Shinagawa-ku, Tokyo","141-8625",{"type":34,"coordinates":235},[236,237],139.69171,35.6895,{"lat":237,"lon":236},{"type":240,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100399182","phase-2-a-study-to-evaluate-the-efficacy-drug-levels-and-safety-of-luspatercept-ace-536-for-the-treatment-of-anemia-due-to-ipss-r-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-in-chinese-and-japanese-participants-with-ring-sideroblasts-who-require-red-blood-cell-transfusions-100399182",false,"NCT04477850","A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions","A Phase 2, Multicenter, Single-Arm Bridging Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes(MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions","Inclusion Criteria:\n\n* Refractory or intolerant to, or ineligible for, prior Erythropoiesis stimulating agent (ESA) treatment as defined by any one of the following: Refractory to prior ESA treatment, Intolerant to prior ESA treatment, or ESA ineligible.\n* previously treated with an ESA or granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, both agents must have been discontinued ≥ 4 weeks prior to date of luspatercept treatment\n* Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2\n\nExclusion Criteria:\n\n* Prior therapy with disease modifying agents for underlying MDS disease\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding\n* Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) or alanine aminotransferase\u002Fserum glutamic pyruvic transaminase (ALT\u002FSGPT) ≥ 3.0 x upper limit of normal (ULN)\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply","ALL","20 Years",{"count":251,"type":252},30,"ACTUAL","INTERVENTIONAL",[255],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese participants with ring sideroblasts who require Red Blood Cells (RBC) transfusions.",[258],"Myelodysplastic Syndromes",[258,260,21,261,17],"MDS","Anemia","COMPLETED","2026-04-29",{"date":265,"type":252},"2026-05-05",{"date":267,"type":252},"2020-11-30",{"date":269,"type":252},"2026-04-08",{"name":5,"class":6},25]