[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tpo-receptor-agonists\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tpo-receptor-agonists":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100563262",false,"NCT06613880","Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia","A Prospective, Single Center, Single-arm Study on the Efficacy and Safety of Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia","Inclusion Criteria:\n\n* Age ≥ 12 years\n* Diagnosis of severe or very severe aplastic anemia\n* Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation\n* ECOG performance status ≤2\n* Willing and able to comply with the requirements for this study and written informed consent.\n\nExclusion Criteria:\n\n* Received \\> 4 weeks of TPO-RA drug before treatment\n* Received \\> 4 weeks of immunosuppressive therapy before treatment\n* History of thromboembolic disease\n* Intolerance to Romiplostim N01 or cyclosporine\n* Allergy to ALG\n* Presence of uncontrolled active infection\n* Presence of uncontrolled hypertension (≥140\u002F90mmHg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol\u002FL or random blood glucose ≥ 11.1 mmol\u002FL)\n* Abnormal liver and kidney function: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \\> 3 ULN, creatinine ≥ 2.5 ULN\n* History of chemoradiotherapy for malignant solid tumors\n* History of other systemic serious illnesses\n* Females who are pregnant\u002Flactating or need pregnancy\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above","ALL","12 Years",{"count":18,"type":19},48,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.",[25,26],"Aplastic Anemia","TPO Receptor Agonists",[28,29],"Severe aplastic anemia","Romiplostim N01","RECRUITING","2024-11-29",{"date":33,"type":34},"2024-12-04","ACTUAL",{"date":36,"type":34},"2024-10-24",{"date":38,"type":19},"2026-09-30",{"name":40,"class":41},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",""]