[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585178":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":51,"collaborators":19,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":19,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Romiplostim N01","EXPERIMENTAL","Romiplostim N01 will be administered once weekly via subcutaneous injection upon the occurrence of Grade 3 thrombocytopenia (platelet count \\\u003C 50×10⁹\u002FL) following leukemia treatment. The recommended initial dose is 5 µg\u002Fkg, with a maximum single dose not exceeding 250 µg. A maximum of 8 doses may be administered during the treatment period.",[13],"Drug: Romiplostim N01",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Romiplostim N01 will be administered via subcutaneous injection once weekly when patients develop Grade 3 thrombocytopenia (platelet count \\\u003C 50×10⁹\u002FL) following leukemia treatment. The recommended initial dose is 5 µg\u002Fkg, with a maximum single dose not exceeding 250 µg. Treatment may continue for up to 8 doses.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Xiaoyu Zhu, Ph.D","The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","0551-62283347","xiaoyuz@ustc.edu.cn",{"name":31,"role":27,"phone":28,"phoneExt":19,"email":32},"Aijie Huang, M.D","huangaijie@mail.ustc.edu.cn",[34],{"facility":23,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Hefei","Anhui","230036","China","CN",{"type":42,"coordinates":43},"Point",[44,45],117.28083,31.86389,{"lat":45,"lon":44},[48,50],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":49},"xiaoyuz@ustc.cn",{"name":31,"role":27,"phone":28,"phoneExt":19,"email":32},{"type":52,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100585178","phase-2-efficacy-and-safety-study-of-romiplostim-n01-for-cancer-treatment-induced-thrombocytopenia-ctit-in-the-treatment-of-leukemia-100585178",false,"NCT06898983","Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive, regardless of sex;\n* Histologically or pathologically confirmed diagnosis of leukemia;\n* Patients with cancer treatment-induced thrombocytopenia (CTIT) in patients with leukemia due to antitumor therapy, with platelet count \\\u003C 50×10⁹\u002FL;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Subjects of childbearing potential agree to use reliable methods of contraception throughout the study period (including male or female condoms, contraceptive foam, gel, film, cream, suppository, abstinence, or intrauterine device);\n* Patients considered by the investigator to potentially benefit from the study treatment;\n* Voluntarily agrees to participate in the clinical trial, is fully informed of the study procedures, and has signed the written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Known hypersensitivity to Romiplostim N01;\n* Presence of hematologic disorders other than cancer treatment-induced thrombocytopenia (CTIT) caused by leukemia treatment, including but not limited to primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, or myelodysplastic syndromes;\n* History of thrombocytopenia due to causes other than CTIT within 6 months prior to screening, including but not limited to chronic liver disease, hypersplenism, infections, or bleeding disorders;\n* History of severe thrombotic events or known risk factors for thrombosis, or active thromboembolism requiring anticoagulation therapy;\n* Severe bleeding within 2 weeks prior to screening (requiring more than 2 units of red blood cell transfusion or a sudden ≥10% drop in hematocrit);\n* Use of thrombopoietin receptor agonists (e.g., eltrombopag), recombinant human thrombopoietin (rhTPO), or interleukin-11 (IL-11) within 1 month prior to screening;\n* HIV infection;\n* Chronic active hepatitis B or hepatitis C infection;\n* Presence of severe infection or serious comorbidities involving the heart, liver, lungs, kidneys, nervous system, or metabolic diseases;\n* Participation in any investigational drug or device clinical trial within 28 days prior to baseline visit;\n* Subjects with cognitive impairment or uncontrolled psychiatric disorders;\n* Refusal of the subject and\u002For legal representative to receive Romiplostim N01 treatment;\n* Deemed unsuitable for enrollment by the investigator (e.g., comorbid conditions that may compromise subject safety or anticipated treatment non-adherence due to financial or other constraints).","ALL","18 Years","75 Years",{"count":63,"type":64},97,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia",[70],"Cancer Treatment-induced Thrombocytopenia (CTIT)","2026-07-09",{"date":73,"type":74},"2026-07-10","ACTUAL",{"date":76,"type":74},"2025-07-14",{"date":78,"type":64},"2027-02-28",{"name":5,"class":6},1]