[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531655":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":208,"collaborators":211,"id":227,"slug":30,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":228,"sex":234,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":30,"studyType":240,"phases":241,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"avatrombopag","EXPERIMENTAL","Avatrombopag 20 mg\u002Fd will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed.\n\nAdjustment indication:\n\nWhen PLT\\\u003C50×10\\^9\u002FL or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg\u002Fd; When the dosage has been increased to 40 mg\u002Fd, and PLT≥80×10\\^9\u002FL excluding the factor of PLT transfusion, decrease the dosage to 20 mg\u002Fd; When PLT≥80×10\\^9\u002FL for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10\\^9\u002FL excluding the factor of PLT transfusion, stop administration; When PLT\\\u003C50×10\\^9\u002FL or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg\u002Fd.\n\nPLT transfusion Indication: When PLT\\\u003C20×10\\^9\u002FL, and\u002For with the symptom or risk of bleeding.",[13],"Drug: avatrombopag",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo 20 mg\u002Fd will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed.\n\nAdjustment indication:\n\nWhen PLT\\\u003C50×10\\^9\u002FL or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg\u002Fd; When the dosage has been increased to 40 mg\u002Fd, and PLT≥80×10\\^9\u002FL excluding the factor of PLT transfusion, decrease the dosage to 20 mg\u002Fd; When PLT≥80×10\\^9\u002FL for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10\\^9\u002FL excluding the factor of PLT transfusion, stop administration; When PLT\\\u003C50×10\\^9\u002FL or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg\u002Fd.\n\nPLT transfusion Indication: When PLT\\\u003C20×10\\^9\u002FL, and\u002For with the symptom or risk of bleeding.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","The avatrombopag 20mg\u002Fd will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\\\u003C50×10\\^9\u002FL or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase avatrombopag dosage to 40 mg\u002Fd; When PLT≥80×10\\^9\u002FL and without PLT transfusion within avatrombopag dosage at 40 mg\u002Fd, decrease avatrombopag dosage to 20 mg\u002Fd; When PLT≥80×10\\^9\u002FL for 7 consecutive days or PLT≥300×10\\^9\u002FL and without PLT transfusion, stop avatrombopag; When PLT\\\u003C50×10\\^9\u002FL or PLT transfusion-dependent after stopping avatrombopag , reuse avatrombopag at 40 mg\u002Fd.",[9],[26],"Doptelet",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"The placebo 20mg\u002Fd will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\\\u003C50×10\\^9\u002FL or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase placebo dosage to 40 mg\u002Fd; When PLT≥80×10\\^9\u002FL and without PLT transfusion within placebo dosage at 40 mg\u002Fd, decrease placebo dosage to 20 mg\u002Fd; When PLT≥80×10\\^9\u002FL for 7 consecutive days or PLT≥300×10\\^9\u002FL and without PLT transfusion, stop placebo; When PLT\\\u003C50×10\\^9\u002FL or PLT transfusion-dependent after stopping placebo, reuse placebo at 40 mg\u002Fd.",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Xiaohui Zhang","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Haixia Fu","CONTACT","13581830157","fuhaixia_210@163.com",[42,60,73,84,96,108,120,128,141,153,165,176,183,197],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Beijing","Beijing Municipality","100044","China",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55,58],{"name":56,"role":38,"phone":30,"phoneExt":30,"email":57},"Xiaohui Zhang, MD","zhangxiaohui@bjmu.edu.cn",{"name":59,"role":38,"phone":39,"phoneExt":30,"email":40},"Haixia Fu, MD",{"facility":61,"status":62,"city":63,"state":64,"zip":30,"country":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Guangzhou First People's Hospital, School of Medicine, South China University of Technology","NOT_YET_RECRUITING","Guangzhou","Guangdong",{"type":49,"coordinates":66},[67,68],113.25,23.11667,{"lat":68,"lon":67},[71],{"name":72,"role":38,"phone":30,"phoneExt":30,"email":30},"Shunqing Wang",{"facility":74,"status":43,"city":75,"state":64,"zip":30,"country":47,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Peking University Shenzhen Hospital","Shenzhen",{"type":49,"coordinates":77},[78,79],114.0683,22.54554,{"lat":79,"lon":78},[82],{"name":83,"role":38,"phone":30,"phoneExt":30,"email":30},"Hongyu Zhang",{"facility":85,"status":62,"city":86,"state":87,"zip":30,"country":47,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"The First Affiliated Hospital, Harbin Medical University","Harbin","Heilongjiang",{"type":49,"coordinates":89},[90,91],126.65,45.75,{"lat":91,"lon":90},[94],{"name":95,"role":38,"phone":30,"phoneExt":30,"email":30},"Shengjin Fan",{"facility":97,"status":62,"city":98,"state":99,"zip":30,"country":47,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan",{"type":49,"coordinates":101},[102,103],113.64861,34.75778,{"lat":103,"lon":102},[106],{"name":107,"role":38,"phone":30,"phoneExt":30,"email":30},"Zhongxing Jiang",{"facility":109,"status":62,"city":110,"state":111,"zip":30,"country":47,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei",{"type":49,"coordinates":113},[114,115],114.26667,30.58333,{"lat":115,"lon":114},[118],{"name":119,"role":38,"phone":30,"phoneExt":30,"email":30},"Yicheng Zhang",{"facility":121,"status":62,"city":110,"state":111,"zip":30,"country":47,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"type":49,"coordinates":123},[114,115],{"lat":115,"lon":114},[126],{"name":127,"role":38,"phone":30,"phoneExt":30,"email":30},"Linghui Xia",{"facility":129,"status":62,"city":130,"state":131,"zip":132,"country":47,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Xiangya Hospital, Central South University","Changsha","Hunan","410008",{"type":49,"coordinates":134},[135,136],112.97087,28.19874,{"lat":136,"lon":135},[139],{"name":140,"role":38,"phone":30,"phoneExt":30,"email":30},"Yajing Xu",{"facility":142,"status":62,"city":143,"state":144,"zip":30,"country":47,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":49,"coordinates":146},[147,148],115.85306,28.68396,{"lat":148,"lon":147},[151],{"name":152,"role":38,"phone":30,"phoneExt":30,"email":30},"Fei Li",{"facility":154,"status":62,"city":155,"state":156,"zip":30,"country":47,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Shanxi Tumor Hospital Affiliated to Shanxi Medical University","Taiyuan","Shanxi",{"type":49,"coordinates":158},[159,160],112.56028,37.86944,{"lat":160,"lon":159},[163],{"name":164,"role":38,"phone":30,"phoneExt":30,"email":30},"Liping Su",{"facility":166,"status":62,"city":167,"state":156,"zip":30,"country":47,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Tangdu Hospital, PLA Air Force Military Medical University","Xi’an",{"type":49,"coordinates":169},[170,171],113.52486,35.99785,{"lat":171,"lon":170},[174],{"name":175,"role":38,"phone":30,"phoneExt":30,"email":30},"Li Liu",{"facility":177,"status":62,"city":178,"state":179,"zip":30,"country":47,"cosmosGeoPoint":30,"geoPoint":30,"contacts":180},"Xinqiao Hospital, Army Military Medical University","Chongqing","Sichuan",[181],{"name":182,"role":38,"phone":30,"phoneExt":30,"email":30},"Xi Zhang",{"facility":184,"status":62,"city":185,"state":186,"zip":187,"country":47,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","Kunming","Yunnan","650100",{"type":49,"coordinates":189},[190,191],102.71833,25.03889,{"lat":191,"lon":190},[194],{"name":195,"role":38,"phone":30,"phoneExt":30,"email":196},"Sanbin Wang","Sanbin1011@163.com",{"facility":198,"status":62,"city":199,"state":30,"zip":30,"country":47,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Chinese Academy of Medical Sciences & Peking Union Medical College","Tianjin",{"type":49,"coordinates":201},[202,203],117.17667,39.14222,{"lat":203,"lon":202},[206],{"name":207,"role":38,"phone":30,"phoneExt":30,"email":30},"Erlie Jiang",{"type":34,"investigatorFullName":209,"investigatorTitle":210,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Xiao Hui Zhang","Vice president of Peking Univeristy Institute of Hematology",[212,214,216,218,219,221,223,224,226],{"name":213,"class":6},"Xiangya Hospital of Central South University",{"name":215,"class":6},"Sichuan Provincial People's Hospital",{"name":217,"class":6},"First Affiliated Hospital of Harbin Medical University",{"name":97,"class":6},{"name":220,"class":6},"First Affiliated Hospital of Xinjiang Medical University",{"name":222,"class":6},"Shanxi Bethune Hospital",{"name":184,"class":6},{"name":225,"class":6},"Tang-Du Hospital",{"name":142,"class":6},"100531655",false,"NCT06202625","Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT","Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haploidentical Hematopoietic Stem Cell Transplantation: Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study","Haplo-HSCT","Inclusion Criteria:\n\n1. Male or female, aged between 18-65 years;\n2. PLT\\\u003C20×10\\^9\u002FL or transfusion dependent on +D7 after haplo-HSCT;\n3. Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.\n\nExclusion Criteria:\n\n1. With active infection;\n2. ALT or AST\\>3ULN, or total Bil\\>2ULN\n3. Ccr\\\u003C50 mL\u002Fmin;\n4. With the history of arteriovenous thrombosis;\n5. With history of cardiovascular disease (such as NYHA Class III\u002FIV congestive heart failure, arrhythmia that increases the risk of thromboembolic events \\[such as atrial fibrillation\\] and angina), and subjects who have undergone coronary stent implantation, angioplasty, or coronary artery bypass grafting;\n6. With treatment of drugs to promote platelet production two weekes before enrollment, including but not limited to rhTPO and TPO-RA;\n7. HBsAg or anti-HCV or anti-HIV positive;\n8. Known to be allergic to avatrombopag and any of its excipients;\n9. With secondary or multiple HSCT;\n10. Females who were pregnant or breastfeeding or who had fertile ability but refuse to take effective contraceptive measures during and one month after this trial;\n11. With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;\n12. Deemed unsuitable for enrollment by the investigator for any history of or concomitant medical condition.\n13. Concomitant medication:The rhIL-11, rhTPO or TPO-RA(such as eltrombopag, hetrombopag and romiplostim) and desitabine, etc. were not allowed for use during this trial.","ALL","18 Years","65 Years",{"count":238,"type":239},142,"ESTIMATED","INTERVENTIONAL",[242,243],"PHASE2","PHASE3","In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.",[246,247],"Thrombocytopenia","Stem Cell Transplant Complications",[246,249,250],"hematopoietic stem cell transplantation","haploidentical","2024-09-29",{"date":253,"type":254},"2024-10-01","ACTUAL",{"date":256,"type":254},"2024-05-13",{"date":258,"type":239},"2025-10-30",{"name":5,"class":6},14]