[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618955":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":35,"responsibleParty":133,"collaborators":26,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":26,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":26,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":26,"overallStatus":38,"whyStopped":26,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Luspatercept(Reblozyl) combined with low-dose thalidomide","EXPERIMENTAL","The subjects in the intervention group were treated with Luspatercept (starting dose 1.0 mg\u002Fkg, once every 21 days) combined with low-dose thalidomide (starting dose level 50 mg\u002Fd) for 48 weeks.",[13],"Drug: Luspatercept combined with low-dose thalidomide",{"label":15,"type":16,"description":17,"interventionNames":18},"Luspatercept plus placebo","PLACEBO_COMPARATOR","The control group was treated with Luspatercept (starting dose level 1.0 mg\u002Fkg every 21 days) plus placebo (starting dose level 50 mg\u002Fd) for 48 weeks.",[19],"Drug: Luspatercept plus placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Luspatercept combined with low-dose thalidomide","The intervention group was treated with Luspatercept (starting dose level 1.0 mg\u002Fkg, once every 21 days) combined with low-dose thalidomide (starting dose level 50 mg\u002Fd) for 48 weeks.",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Rongrong Liu","CONTACT","+86 0771 5356510","liurongrong@stu.gxmu.edu.cn",[36,53,66,74,87,97,109,122],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Southern Medical University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518100","China","CN",{"type":45,"coordinates":46},"Point",[47,48],114.0683,22.54554,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":26,"phoneExt":26,"email":26},"Zhiqiang Sun",{"facility":54,"status":38,"city":55,"state":56,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Affiliated Hospital of Youjiang Medical College for Nationalities","Baise City","Guangxi","533000",{"type":45,"coordinates":59},[60,61],106.62684,23.89013,{"lat":61,"lon":60},[64],{"name":65,"role":32,"phone":26,"phoneExt":26,"email":26},"Xiaochao Wang",{"facility":67,"status":38,"city":55,"state":56,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Baise People's Hospital",{"type":45,"coordinates":69},[60,61],{"lat":61,"lon":60},[72],{"name":73,"role":32,"phone":26,"phoneExt":26,"email":26},"Yan Huang",{"facility":75,"status":38,"city":76,"state":56,"zip":77,"country":42,"countryCode":43,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Liuzhou People's Hospital","Liuzhou","545007",{"type":45,"coordinates":79},[80,81],109.40698,24.32405,{"lat":81,"lon":80},[84],{"name":85,"role":32,"phone":86,"phoneExt":26,"email":26},"Qiangqiang Zhao","+86 07714712364",{"facility":88,"status":38,"city":76,"state":56,"zip":77,"country":42,"countryCode":43,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Liuzhou Workers' Hospital",{"type":45,"coordinates":90},[80,81],{"lat":81,"lon":80},[93],{"name":94,"role":32,"phone":95,"phoneExt":26,"email":96},"Chunjie Qin","+86 0772 3805890","qinchunjie1@163.com",{"facility":98,"status":38,"city":99,"state":56,"zip":100,"country":42,"countryCode":43,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Yulin First People's Hospital","Yulin","537000",{"type":45,"coordinates":102},[103,104],110.14686,22.6305,{"lat":104,"lon":103},[107],{"name":108,"role":32,"phone":26,"phoneExt":26,"email":26},"Jun Wan",{"facility":110,"status":38,"city":111,"state":112,"zip":113,"country":42,"countryCode":43,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Yunnan Provincial First People's Hospital","Kunming","Yunnan","650100",{"type":45,"coordinates":115},[116,117],102.71833,25.03889,{"lat":117,"lon":116},[120],{"name":121,"role":32,"phone":26,"phoneExt":26,"email":26},"Yajie Wang",{"facility":123,"status":38,"city":124,"state":26,"zip":125,"country":42,"countryCode":43,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"The First Affiliated Hospital of Guangxi Medical University","Naning","530000",{"type":45,"coordinates":127},[128,129],106.334,24.0658,{"lat":129,"lon":128},[132],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},{"type":134,"investigatorFullName":31,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","consultant; professor","100618955","phase-2-evaluating-the-clinical-efficacy-and-safety-of-luspatercept-combined-with-thalidomide-in-the-treatment-of--tdt-patients-100618955",false,"NCT07338344","Evaluating the Clinical Efficacy and Safety of Luspatercept Combined With Thalidomide in the Treatment of β-TDT Patients","Evaluation of the Clinical Efficacy and Safety of Luspatercept Combined With Low-dose Thalidomide Versus Luspatercept Alone in the Treatment of Adult Patients With Transfusion-dependent β-thalassemia","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of gender;\n* Patients with transfusion-dependent β-thalassemia;\n* Intended treatment with rotecept combined with low-dose thalidomide or rotecept alone;\n* Requires regular red blood cell transfusions (6-30 RBC units (International Units) within 24 weeks prior to randomization, with a transfusion-free interval of ≤ 42 days);\n* ECOG performance status 0-1;\n* Patients (or legal guardians) voluntarily participate in the study and provide signed informed consent.\n\nExclusion Criteria:\n\n* A diagnosis of α-thalassemia minor, Hb Bart's edema, hemoglobin S\u002Fβ-thalassemia, or myelodysplastic anemia (combination of β-thalassemia and α-thalassemia is permitted);\n* Anemia related to nutritional deficiency, anemia of chronic disease, autoimmune hemolytic anemia, or any other hemolytic anemia (e.g., severe G6PD deficiency, pyruvate kinase deficiency);\n* A bleeding disorder manifesting as frequent bleeding (e.g., menorrhagia, epistaxis, coagulopathy);\n* Hemolysis unrelated to thalassemia within the past 8 weeks, such as after use of hemolytic-inducing medications (e.g., antimalarials, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]);\n* Use of long-term anticoagulant therapy, unless discontinued at least 28 days before randomization. Prophylactic anticoagulant therapy for surgery or high-risk procedures, as well as low-molecular-weight heparin and long-term aspirin therapy for superficial venous thrombosis, are permitted.\n* Use of thalidomide alone, erythropoiesis-stimulating drugs (ESA), or hydroxyurea within the past 24 weeks.\n* Use of long-term systemic glucocorticoids within the past 12 weeks.\n* Use of cytotoxic drugs, immunosuppressants, or other investigational drugs within the past 28 days.\n* HIV positive and\u002For active HCV or HBV infection.\n* Hepatic and renal insufficiency (liver insufficiency, i.e., aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN); renal insufficiency, i.e., serum creatinine ≥3× upper limit of normal (ULN) or creatinine clearance less than 30). mL\u002Fmin), history of malignancy (unless cured and\u002For with no known active disease);\n* Women who are pregnant, plan to become pregnant during the study, or are breastfeeding;\n* Previous thalassemia gene therapy or hematopoietic stem cell transplantation (HSCT);\n* Platelet count \\\u003C 70 × 109\u002FL, if not associated with hypersplenism, or platelet count \\> 1,000 × 109\u002FL;\n* Other conditions deemed unsuitable for participation in this clinical trial by the investigator.","ALL","18 Years","75 Years",{"count":147,"type":148},78,"ESTIMATED","INTERVENTIONAL",[151],"PHASE2","β-thalassemia is one of the most common inherited hemoglobinopathies worldwide and a major public health issue that severely impacts birth quality, human health, and social progress. Currently, there are limited clinical drugs specifically designed to treat patients with β-thalassemia. This clinical trial aims to evaluate the efficacy and safety of luspatercept combined with low-dose thalidomide compared with luspatercept alone in patients with thalassemia. Key questions to be answered include:\n\n* Does luspatercept combined with low-dose thalidomide reduce the transfusion burden in patients with β-thalassemia major?\n* What medical problems may occur when patients receive luspatercept combined with low-dose thalidomide? In this clinical trial, participants were randomly assigned in a 1:1 ratio to either an intervention group (luspatercept combined with low-dose thalidomide) or a control group (luspatercept combined with placebo) using a central randomization system. The clinical efficacy and safety of the two groups were evaluated. The primary outcome measure was the clinical efficacy of luspatercept combined with low-dose thalidomide in reducing the transfusion burden in patients with β-thalassemia major.",[154],"Transfusion-dependent β-thalassemia Patients","2026-01-05",{"date":157,"type":158},"2026-01-13","ACTUAL",{"date":160,"type":148},"2026-02-01",{"date":162,"type":148},"2027-12-31",{"name":31,"class":6},8]