[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563262":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"p-ALG+Romiplostim N01+CsA","EXPERIMENTAL","The maximum screening period was 4 weeks, and after entering the treatment period, the patients were treated with p-ALG combined with cyclosporine and Romiplostim N01. Symptomatic leukocyte elevation, blood transfusion support, and anti-infective therapy are allowed during this period, according to the patient's blood routine. If a patient has a serious adverse event during treatment, it will be treated according to the criteria for suspension and recovery.",[13],"Drug: standard IST combined with Romiplostim N01",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","standard IST combined with Romiplostim N01","Romiplostim N01 is a class of TPO receptor agonists. Its TPO peptide can bind to TPO receptors on megakaryocyte precursors in the bone marrow and activate them, triggering a series of intracellular signalling pathways, including JAK2\u002FSTAT5, PI3K\u002FAkt, MEK\u002FERK, and p38, which ultimately lead to gene transcription and increased megakaryocyte proliferation and differentiation.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jun Shi, PhD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Lele Zhang, PhD","CONTACT","15811139278","zhanglele@ihcams.ac.cn",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":20},"Meili Ge, PhD",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Regenerative Medicine Center and Red Blood Cell Disorders Center","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":42,"coordinates":43},"Point",[44,45],117.17667,39.14222,{"lat":45,"lon":44},[48],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":54},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY","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":65,"type":66},48,"ESTIMATED","INTERVENTIONAL",[69],"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.",[72,73],"Aplastic Anemia","TPO Receptor Agonists",[75,76],"Severe aplastic anemia","Romiplostim N01","2024-11-29",{"date":79,"type":80},"2024-12-04","ACTUAL",{"date":82,"type":80},"2024-10-24",{"date":84,"type":66},"2026-09-30",{"name":5,"class":6},1]