[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100563262","phase-2-standard-immunosuppressive-therapy-combined-with-romiplostim-n01-as-first-line-treatment-for-severe-aplastic-anemia-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":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Aplastic Anemia","TPO Receptor Agonists",[29,30],"Severe aplastic anemia","Romiplostim N01","RECRUITING","2024-11-29",{"date":34,"type":35},"2024-12-04","ACTUAL",{"date":37,"type":35},"2024-10-24",{"date":39,"type":20},"2026-09-30",{"name":41,"class":42},"Institute of Hematology & Blood Diseases Hospital, China","OTHER"]