[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617669":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":29,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Romiplostim N01 Treatment Arm","EXPERIMENTAL",null,[13,14],"Drug: Romiplostim N01","Other: Standard Supportive Care",{"label":16,"type":17,"description":11,"interventionNames":18},"Standard Care Control Arm","ACTIVE_COMPARATOR",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Romiplostim N01","Romiplostim N01 is a thrombopoietin receptor agonist (TPO-RA) administered subcutaneously once weekly to promote platelet recovery after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT). The starting dose is 5 µg\u002Fkg, adjusted up to 10 µg\u002Fkg according to platelet response. Treatment continues for up to 4 weeks or until platelet counts reach ≥100 × 10⁹\u002FL without transfusion. Standard post-transplant supportive care is provided to all participants.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Standard Supportive Care","Participants in the control arm will receive standard post-transplant supportive care, including transfusions, growth factors (G-CSF, ESA), and infection prophylaxis as clinically indicated, but will not receive Romiplostim or any other thrombopoietin receptor agonist.",[9,16],[30],{"facility":31,"status":32,"city":33,"state":11,"zip":11,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"The First Affiliated Hospital, College of Medicine, Zhejiang University","RECRUITING","Hangzhou","China","CN",{"type":37,"coordinates":38},"Point",[39,40],120.16142,30.29365,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Yi Luo, MD","CONTACT","86-1366660","luoyijr@zju.edu.com",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":60,"type":61},130,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67,68,69,70],"Acute Myeloid Leukemia","MDS (Myelodysplastic Syndrome)","Delayed Platelet Engraftment","HSCT","2026-01-26",{"date":73,"type":74},"2026-01-28","ACTUAL",{"date":76,"type":74},"2025-06-01",{"date":78,"type":61},"2027-12",{"name":5,"class":6},1]