[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597802":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":55,"collaborators":57,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":19,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":19,"enrollmentInfo":80,"targetDuration":19,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":19,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Romiplostim N01","EXPERIMENTAL","50 enrolled subjects will be picked up to take Romiplostim N01 at the indicated dose.",[13],"Drug: Romiplostim N01",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg\u002Fkg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg\u002Fkg each week, up to a maximum of 10 µg\u002Fkg, until the platelet count reaches ≥ 50 × 10\\^9\u002FL. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Yunfei Chen, MD","Chinese Academy of Medical Science and Blood Disease Hospital","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Ting Sun, MD","CONTACT","+8615822339131","sunting@ihcams.ac.cn",{"name":22,"role":28,"phone":32,"phoneExt":19,"email":33},"8618502220788","henyunfei@ihcams.ac.cn",[35],{"facility":23,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Tianjin","Tianjin Municipality","301600","China","CN",{"type":43,"coordinates":44},"Point",[45,46],117.17667,39.14222,{"lat":46,"lon":45},[49,51],{"name":27,"role":28,"phone":50,"phoneExt":19,"email":30},"8623608180",{"name":52,"role":28,"phone":53,"phoneExt":19,"email":54},"Lei Zhang, MD","8623608185","zhanglei1@ihcams.ac.cn",{"type":56,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[58,60,62,64,66,69],{"name":59,"class":6},"Tianjin Medical University Cancer Institute and Hospital",{"name":61,"class":6},"Tianjin Medical University Second Hospital",{"name":63,"class":6},"Tianjin Third Central Hospital",{"name":65,"class":6},"Tianjin People's Hospital",{"name":67,"class":68},"Henan Cancer Hospital","OTHER_GOV",{"name":70,"class":6},"The Second Affiliated Hospital of Kunming Medical University","100597802","phase-2-romiplostim-n01-for-chemotherapy-induced-thrombocytopenia-100597802",false,"NCT07063225","Romiplostim N01 for Chemotherapy-induced Thrombocytopenia","Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study","Inclusion Criteria:\n\n* Age: 18 years or above, gender not restricted;\n* Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u\u002Fkg\u002Fd or higher, and the platelet count remains less than 30×10\\^9\u002FL, defined as refractory CTIT);\n* Patients who have stopped chemotherapy and radiotherapy for more than 1 month;\n* Patients with platelet count at enrollment \\\u003C 30×10\\^9\u002FL;\n* Patients with platelet count remains \\\u003C 30×10\\^9\u002FL for more than 1 month;\n* Patients with expected survival period ≥ 6 months;\n* Patients with liver and kidney function \\\u003C 1.5× upper limit of normal value, physical examination qualified;\n* Patients with ECOG physical status score ≤ 2 points;\n* Patients with Cardiac function: New York Heart Association cardiac function classification is grade 2 or below;\n* Patients who is voluntary to sign the informed consent form;\n\nExclusion Criteria:\n\n* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；\n* Patients with poor compliance;\n* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and\u002For hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.\n* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past；\n* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；\n* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；\n* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；\n* Patients with sepsis or patients with other irregular bleeding；\n* Patients taking antiplatelet drugs at the same time；\n* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients； Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \\[NYHA\\] Grade III\u002FIV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \\>450msec or QTc \\> 480 for patients with a Bundle Branch Block;\n* Researchers believe that patients should not participate in the test of any other condition.","ALL","18 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors",[88,9],"Chemotherapy-induced Thrombocytopenia","2025-07-03",{"date":91,"type":92},"2025-07-14","ACTUAL",{"date":94,"type":82},"2025-08",{"date":96,"type":82},"2026-08",{"name":5,"class":6},1]