[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528749":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Hematology department of the 920th hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"luspatercept arm","EXPERIMENTAL","Luspatercept was given once subcutaneously every 3 weeks for 24 weeks in the treatment period, . Luspatercept was started at 1·0 mg\u002Fkg with titration up to 1·25 mg\u002Fkg, or reduction in the event of toxicity or excessive haemoglobin concentration increase.. During the treatment, the hemoglobin of patients before each injection of luspatercept should be monitored, and the common adverse reactions (AE) should be monitored. According to the judgment and practice of clinicians, the best supportive treatment, including blood transfusion, iron chelation therapy, and anti-infection treatment, should be provided for patients receiving luspatercept treatment. If the patient has blood transfusion, it is necessary to obtain the blood transfusion record from the hospital system.Concomitant use of iron chelating agents was also recorded.",[13],"Drug: luspatercept",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","luspatercept","Adult patients with TD thalassemia were given luspatercept subcutaneous injection.",[9],null,[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Chaoen Zhen, MD","CONTACT","18087991755","+86","zce163163@163.com",{"name":29,"role":24,"phone":30,"phoneExt":26,"email":20},"Liu Liu, MD","0871-64774206",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","RECRUITING","Kunming","Yunnan","650000","China","CN",{"type":41,"coordinates":42},"Point",[43,44],102.71833,25.03889,{"lat":44,"lon":43},[47],{"name":48,"role":24,"phone":20,"phoneExt":20,"email":20},"Lin Liu",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100528749","clinical-observation-of-luspatercept-in-treatment-of-chinese-adult--thalassaemia-patients-with-td--thalassemia-100528749",false,"NCT06164821","Clinical Observation of Luspatercept in Treatment of Chinese Adult β-thalassaemia Patients With TD β-thalassemia","Efficary and Safety of Luspatercept for Treatment of Anaemia in Transfusion-dependent β-thalassaemia in Southwest China","Inclusion Criteria:\n\n1. ≥18 years old;\n2. A clear diagnosis of transfusion-dependent β-thalassemia (including αβ mixed type) with red blood cell transfusion ≤15u within 24 weeks before enrollment (one unit of red blood cell in overseas clinical research is 200-350ml packed red blood cells, which should be converted according to Chinese clinical practice);\n3. Voluntarily participate in the study and sign the informed consent;\n\nExclusion Criteria:\n\n1. pregnant or lactating women;\n2. Allergic to luspatercept and\u002For luspatercept for injection excipients;\n3. Severe liver dysfunction: Liver enzymes (alanine aminotransferase ALT or aspartate aminotransferase AST) ≥ 3 times normal value.;\n4. Severe renal injury: eGFR\\\u003C30 ml\u002Fmin\u002F1.73m3 or end-stage renal disease;\n5. heart disease, New York Heart Association (NYHA) class 3 or higher heart failure, or the need for treatment Severe arrhythmia, or recent myocardial infarction within 6 months;\n6. The patient had uncontrolled hypertension;\n7. Patients with a history of deep vein thrombosis or stroke within 24 weeks prior to enrollment.;\n8. Treatment with ESA, luspatercept, thalidomide or hydroxyurea within 12 weeks before enrollment;\n9. Any significant other medical condition, laboratory abnormality, or mental illness;\n10. Investigators deemed enrollment inappropriate.","ALL","18 Years",{"count":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65],"NA","To assesse the efficacy and safety of luspatercept versus placebo in China patients with transfusion-dependent β-thalassaemia.",[68],"Effect of Drug",[17,70],"β-Thalassemia","UNKNOWN","2023-12-19",{"date":74,"type":75},"2023-12-22","ACTUAL",{"date":77,"type":62},"2024-01-01",{"date":79,"type":62},"2024-11-30",{"name":5,"class":6},1]