[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531655":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":209,"collaborators":212,"id":228,"slug":229,"hasResults":230,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":230,"sex":236,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":30,"studyType":242,"phases":243,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},{"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",[42,61,74,85,97,109,121,129,142,154,166,177,184,198],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56,59],{"name":57,"role":38,"phone":30,"phoneExt":30,"email":58},"Xiaohui Zhang, MD","zhangxiaohui@bjmu.edu.cn",{"name":60,"role":38,"phone":39,"phoneExt":30,"email":40},"Haixia Fu, MD",{"facility":62,"status":63,"city":64,"state":65,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Guangzhou First People's Hospital, School of Medicine, South China University of Technology","NOT_YET_RECRUITING","Guangzhou","Guangdong",{"type":50,"coordinates":67},[68,69],113.25,23.11667,{"lat":69,"lon":68},[72],{"name":73,"role":38,"phone":30,"phoneExt":30,"email":30},"Shunqing Wang",{"facility":75,"status":43,"city":76,"state":65,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Peking University Shenzhen Hospital","Shenzhen",{"type":50,"coordinates":78},[79,80],114.0683,22.54554,{"lat":80,"lon":79},[83],{"name":84,"role":38,"phone":30,"phoneExt":30,"email":30},"Hongyu Zhang",{"facility":86,"status":63,"city":87,"state":88,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"The First Affiliated Hospital, Harbin Medical University","Harbin","Heilongjiang",{"type":50,"coordinates":90},[91,92],126.65,45.75,{"lat":92,"lon":91},[95],{"name":96,"role":38,"phone":30,"phoneExt":30,"email":30},"Shengjin Fan",{"facility":98,"status":63,"city":99,"state":100,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan",{"type":50,"coordinates":102},[103,104],113.64861,34.75778,{"lat":104,"lon":103},[107],{"name":108,"role":38,"phone":30,"phoneExt":30,"email":30},"Zhongxing Jiang",{"facility":110,"status":63,"city":111,"state":112,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei",{"type":50,"coordinates":114},[115,116],114.26667,30.58333,{"lat":116,"lon":115},[119],{"name":120,"role":38,"phone":30,"phoneExt":30,"email":30},"Yicheng Zhang",{"facility":122,"status":63,"city":111,"state":112,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"type":50,"coordinates":124},[115,116],{"lat":116,"lon":115},[127],{"name":128,"role":38,"phone":30,"phoneExt":30,"email":30},"Linghui Xia",{"facility":130,"status":63,"city":131,"state":132,"zip":133,"country":47,"countryCode":48,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Xiangya Hospital, Central South University","Changsha","Hunan","410008",{"type":50,"coordinates":135},[136,137],112.97087,28.19874,{"lat":137,"lon":136},[140],{"name":141,"role":38,"phone":30,"phoneExt":30,"email":30},"Yajing Xu",{"facility":143,"status":63,"city":144,"state":145,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":50,"coordinates":147},[148,149],115.85306,28.68396,{"lat":149,"lon":148},[152],{"name":153,"role":38,"phone":30,"phoneExt":30,"email":30},"Fei Li",{"facility":155,"status":63,"city":156,"state":157,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Shanxi Tumor Hospital Affiliated to Shanxi Medical University","Taiyuan","Shanxi",{"type":50,"coordinates":159},[160,161],112.56028,37.86944,{"lat":161,"lon":160},[164],{"name":165,"role":38,"phone":30,"phoneExt":30,"email":30},"Liping Su",{"facility":167,"status":63,"city":168,"state":157,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Tangdu Hospital, PLA Air Force Military Medical University","Xi’an",{"type":50,"coordinates":170},[171,172],113.52486,35.99785,{"lat":172,"lon":171},[175],{"name":176,"role":38,"phone":30,"phoneExt":30,"email":30},"Li Liu",{"facility":178,"status":63,"city":179,"state":180,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":30,"geoPoint":30,"contacts":181},"Xinqiao Hospital, Army Military Medical University","Chongqing","Sichuan",[182],{"name":183,"role":38,"phone":30,"phoneExt":30,"email":30},"Xi Zhang",{"facility":185,"status":63,"city":186,"state":187,"zip":188,"country":47,"countryCode":48,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","Kunming","Yunnan","650100",{"type":50,"coordinates":190},[191,192],102.71833,25.03889,{"lat":192,"lon":191},[195],{"name":196,"role":38,"phone":30,"phoneExt":30,"email":197},"Sanbin Wang","Sanbin1011@163.com",{"facility":199,"status":63,"city":200,"state":30,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Chinese Academy of Medical Sciences & Peking Union Medical College","Tianjin",{"type":50,"coordinates":202},[203,204],117.17667,39.14222,{"lat":204,"lon":203},[207],{"name":208,"role":38,"phone":30,"phoneExt":30,"email":30},"Erlie Jiang",{"type":34,"investigatorFullName":210,"investigatorTitle":211,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Xiao Hui Zhang","Vice president of Peking Univeristy Institute of Hematology",[213,215,217,219,220,222,224,225,227],{"name":214,"class":6},"Xiangya Hospital of Central South University",{"name":216,"class":6},"Sichuan Provincial People's Hospital",{"name":218,"class":6},"First Affiliated Hospital of Harbin Medical University",{"name":98,"class":6},{"name":221,"class":6},"First Affiliated Hospital of Xinjiang Medical University",{"name":223,"class":6},"Shanxi Bethune Hospital",{"name":185,"class":6},{"name":226,"class":6},"Tang-Du Hospital",{"name":143,"class":6},"100531655","phase-2-efficacy-and-safety-of-avatrombopag-in-the-treatment-of-thrombocytopenia-after-haplo-hsct-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":240,"type":241},142,"ESTIMATED","INTERVENTIONAL",[244,245],"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.",[248,249],"Thrombocytopenia","Stem Cell Transplant Complications",[248,251,252],"hematopoietic stem cell transplantation","haploidentical","2024-09-29",{"date":255,"type":256},"2024-10-01","ACTUAL",{"date":258,"type":256},"2024-05-13",{"date":260,"type":241},"2025-10-30",{"name":5,"class":6},14]