[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"delayed-platelet-engraftment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:delayed-platelet-engraftment":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100617669","phase-1-romiplostim-n01-for-platelet-recovery-after-haploidentical-hsct-100617669",false,"NCT07321626","Romiplostim N01 for Platelet Recovery After Haploidentical HSCT","Efficacy and Safety of Romiplostim N01 in Promoting Platelet Reconstruction After Haploidentical Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies","Inclusion Criteria:\n\nPatients with malignant hematologic diseases scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) Age ≥18 years, male or female. ECOG performance status 0-1. Estimated life expectancy \\>6 months. Adequate renal function, defined as:serum creatinine ≤1.5 × upper limit of normal (ULN);Blood urea nitrogen (BUN) ≤1.5 × ULN.\n\nAdequate hepatic function, defined as:Alanine aminotransferase (ALT) ≤2 × ULN.Aspartate aminotransferase (AST) ≤2 × ULN.Total bilirubin ≤1.5 × ULN.\n\nAbility to understand and sign informed consent, and willingness to comply with all study requirements.\n\nExclusion Criteria:\n\nUncontrolled active infection or other active malignancy that could interfere with study participation.\n\nSevere cardiovascular disease, including:New York Heart Association (NYHA) Class III-IV heart failure;Uncontrolled hypertension or hypotension;History of or high risk for thromboembolic events.\n\nReceiving anticoagulation therapy for thrombotic events. Known hypersensitivity to romiplostim or similar agents. Use of rh-TPO or any thrombopoietin receptor agonist (TPO-RA) within 30 days prior to enrollment.\n\nParticipation in another interventional clinical study within 30 days prior to enrollment.\n\nAny other condition that, in the investigator's judgment, makes the patient unsuitable for the study.","ALL","18 Years",{"count":19,"type":20},130,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy and safety of Romiplostim N01 in promoting platelet engraftment after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) in patients with hematologic malignancies.\n\nA total of 130 patients who undergo haplo-HSCT for acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or other hematologic malignancies will be enrolled and randomized 1:1 into a treatment group and a control group. The treatment group will receive Romiplostim N01 subcutaneously once weekly at a starting dose of 5 µg\u002Fkg, with dose adjustments based on platelet counts (maximum 10 µg\u002Fkg), for up to 4 weeks or until platelet counts reach ≥100 × 10⁹\u002FL. The control group will not receive rh-TPO or any thrombopoietin receptor agonist (TPO-RA) therapy. Supportive care including transfusions and growth factors (G-CSF, ESA) is allowed in both groups.\n\nThe primary endpoint is the cumulative platelet engraftment rate by day +21 post-transplant, defined as sustained platelet counts \\> 20 × 10⁹\u002FL for at least 7 consecutive days without transfusion. Secondary endpoints include median time to platelet engraftment, median time to achieve platelet counts ≥ 50 × 10⁹\u002FL and ≥ 100 × 10⁹\u002FL, total platelet transfusion volume, erythroid and neutrophil responses within 4 weeks, and overall hematopoietic recovery. Safety endpoints include the incidence of adverse events, thromboembolic events, and treatment-related serious adverse events.\n\nThe study aims to determine whether early administration of Romiplostim N01 can accelerate platelet recovery and reduce bleeding risk in patients undergoing haplo-HSCT, thereby improving post-transplant outcomes.",[26,27,28,29],"Acute Myeloid Leukemia","MDS (Myelodysplastic Syndrome)","Delayed Platelet Engraftment","HSCT","RECRUITING","2026-01-26",{"date":33,"type":34},"2026-01-28","ACTUAL",{"date":36,"type":34},"2025-06-01",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"First Affiliated Hospital of Zhejiang University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":42},"100579024","hetrombopag-in-promoting-platelet-engraftment-after-auto-hsct-in-children-with-neuroblastoma-100579024","NCT06818916","Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT in Children With Neuroblastoma","Efficacy and Safety of Hetrombopag in Promoting Platelet Engraftment After Autologous Hematopoietic Stem Cell Transplantation in Children With Neuroblastoma","Inclusion Criteria:\n\n* Age\\\u003C18 years old;\n* Diagnosed as neuroblastoma;\n* ECOG ≤ 2;\n* First time receiving autologous hematopoietic stem cell transplantation;\n* The subjects or their legal guardians agree to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* ALT\u002FAST \\> 3 ULN, or TBIL \\> 1.5 ULN;\n* Have experienced congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication treatment within one year prior to enrollment, or have experienced myocardial infarction or cerebral infarction within three months prior to enrollment;\n* Suffering from thromboembolic diseases;\n* Other situations that are not suitable for inclusion in the study determined by researchers.",{"count":51,"type":20},30,[53],"NA","The goal of this clinical trial is to learn if hetrombopag promotes platelet engraftment in neuroblastoma children undergoing autologous hematopoietic stem cell transplantation. The main question it aims to answer is:\n\n· Does drug hetrombopag promote platelet engraftment? Participants will take hetrombopag every day for 6 weeks or until platelet \\> 100\\*10\\^9\u002FL.",[28,56,57],"Neuroblastoma","Autologous Hematopoietic Stem Cell Transplantation",[59,60,61,62,63],"Hetrombopag","delayed platelet engraftment","neuroblastoma","pediatrics","autologous hematopoietic stem cell transplantation","2025-11-26",{"date":66,"type":34},"2025-12-03",{"date":68,"type":34},"2024-06-30",{"date":70,"type":20},"2027-07-31",{"name":72,"class":41},"Beijing Children's Hospital"]