[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430819":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":31,"id":56,"slug":31,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":31,"enrollmentInfo":65,"targetDuration":31,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":31,"overallStatus":38,"whyStopped":31,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","100 subjects will be enrolled with the indicated treatment dose of TPO-RA",[13],"Drug: TPO-RA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TPO-RA","The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10\\^9\u002FL and 150×10\\^9\u002FL according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10\\^9\u002FL, the treatment was stopped. If the platelet count is more than 400×10\\^9\u002FL after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.",[9],[21],"TPO-RAs",[23],{"name":24,"affiliation":5,"role":25},"Lei Zhang","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Wei Liu","CONTACT","+82223909240",null,"liuwei1@ihcams.ac.cn",{"name":24,"role":29,"phone":30,"phoneExt":31,"email":34},"zhanglei1@ihcams.ac.cn",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Institute of Hematology & Blood Diseases Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China",{"type":44,"coordinates":45},"Point",[46,47],117.17667,39.14222,{"lat":47,"lon":46},[50,53],{"name":51,"role":29,"phone":52,"phoneExt":31,"email":34},"Lei Zhang, MD","+862223909240",{"name":24,"role":29,"phone":30,"phoneExt":31,"email":34},{"type":55,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100430819",false,"NCT04890041","TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years","Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study","ITP","Inclusion Criteria:\n\n* Men and women greater than or equal to 14 years of age.\n* Participants diagnosed with primary immune thrombocytopenia with two platelet counts of \\\u003C 30x10\\^9\u002FL or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).\n* Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U\u002Fkg\u002F day × 14-day rhTPO with no response to treatment (platelet count \\\u003C 30×109\u002FL after treatment, or platelet count increase less than twice the baseline value, or with bleeding)\n* Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.\n\nExclusion Criteria:\n\n* Patients diagnosed with secondary immune thrombocytopenia.\n* A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.\n* Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);\n* Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;\n* Have used rituximab in the past 3 months;\n* Splenectomy in recent 3 months;\n* Those who are not considered suitable for this study by the researcher;\n* Women who are pregnant or who intend to become pregnant in the near future are excluded.","ALL","14 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"NA","This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .",[73],"Primary Immune Thrombocytopenic Purpura","2025-02-20",{"date":76,"type":77},"2025-02-24","ACTUAL",{"date":79,"type":77},"2021-05-30",{"date":81,"type":67},"2025-12-31",{"name":5,"class":6},1]