[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636930":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":19,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":19,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":19,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":19},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Romiplostim N01","EXPERIMENTAL","Romiplostim N01 20 µg\u002Fkg",[13],"Drug: Romiplostim N01",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Romiplostim N01 20 µg\u002Fkg subcutaneously once a week for at least 3 months",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Bing Han","CONTACT","+86 13601059938","hanbing_li@sina.com.cn",{"type":27,"investigatorFullName":22,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Professor","100636930","phase-2-romiplostim-n01-in-chemoradiotherapy-induced-aplastic-anemia-100636930",false,"NCT07572084","Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia","Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced Aplastic Anemia: a Single-center, Prospective, Open-label Study","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Diagnosed with relapsed\u002Frefractory chemoradiotherapy-induced AA. Relapsed\u002F refractory was defined as patients who had no response to at least 3 months of cyclosporine or thrombopoietin receptor agonists (TPO-RAs) such as eltrombopag;\n3. At least one of the following conditions must be met: hemoglobin \\\u003C 90 g\u002F L, platelet count \\\u003C 30×109\u002FL, neutrophil count \\\u003C 1.0×109\u002FL;\n4. With baseline liver and kidney functions \\\u003C2 upper limit of normal (ULN);\n5. Without active infection that cannot be controlled by standard treatment;\n6. Signed the informed consent;\n7. ECOG score ≤ 2;\n\nExclusion Criteria:\n\n1. Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc.;\n2. With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics;\n3. Paroxysmal nocturnal hemoglobinuria (PNH) clone ≥ 50%;\n4. Received hematopoietic stem cell transplantation before enrollment;\n5. Received ATG treatment before enrollment;\n6. Severe bleeding or infection that cannot be controlled by standard treatment;\n7. Allergic or intolerant to romiplostim N01;\n8. Active infections of HIV, HCV, or HBV, liver cirrhosis, or portal hypertension\n9. History of malignant tumors within 5 years;\n10. History of arterial or venous thrombosis;\n11. Pregnant or lactating patients;\n12. Participated in other clinical trials within 3 months.","ALL","18 Years",{"count":39,"type":40},43,"ESTIMATED","INTERVENTIONAL",[43],"PHASE2","This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of chemoradiotherapy-induced aplastic anemia (AA)",[46],"Aplastic Anemia","NOT_YET_RECRUITING","2026-05-02",{"date":50,"type":51},"2026-05-07","ACTUAL",{"date":53,"type":40},"2026-04",{"date":55,"type":40},"2029-12",{"name":5,"class":6}]