[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609395":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":19,"collaborators":7,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":27,"acronym":7,"eligibilityCriteria":28,"healthyVolunteers":25,"sex":29,"minAge":7,"maxAge":30,"enrollmentInfo":31,"targetDuration":7,"studyType":34,"phases":7,"briefSummary":35,"conditions":36,"keywords":7,"overallStatus":39,"whyStopped":7,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":7},{"fullName":5,"class":6},"Assiut University","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Safety and efficacy of Romiplostim in Treatment of chronic ITP in children","Children diagnosed with chronic immune thrombocytopenia (ITP) will receive Romiplostim, a thrombopoietin receptor agonist administered as a once-weekly subcutaneous injection. The initial dose will be 1 µg\u002Fkg, with subsequent dose adjustments (up to a maximum of 10 µg\u002Fkg weekly) based on platelet response, in order to maintain platelet counts ≥50 × 10⁹\u002FL while minimizing the risk of bleeding. Treatment duration will be determined according to study protocol, and patients will be monitored regularly for efficacy (platelet count response, bleeding events) and safety (adverse events, laboratory parameters).",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Mostafa Refat Mostafa, Principal Investigator","CONTACT","+201140514880","moustafa.17298696@aun.edu.eg",{"type":20,"investigatorFullName":21,"investigatorTitle":22,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Mostafa Refat Mostafa Ali","Principal Investigator","100609395","safety-and-efficacy-of-romiplostim-in-treatment-of-chronic-itp-in-children-100609395",false,"NCT07214025","Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children","Inclusion Criteria:\n\n* Patients aged between 1 and 18 years\n* Diagnosis of chronic ITP\n* Refractory to or intolerant of first-line therapies (e.g.corticosteroids , intravenous immunoglobulin \\[ IVIG \\] , and oral eltrombopag )\n* Platelet count\\\u003C30,000\u002FµL, or evidence of bleeding or risk of bleeding with platelet count\\\u003C50,000\u002FµL.\n* Written informed consent (or parental\u002Fguardian consent for minors)\n\nExclusion Criteria:\n\n* Evidence of secondary thrombocytopenia (e.g., HIV, HCV, systemic lupus erythematosus)\n* congenital thrombocytopenia\n* Age \\\u003C 1year or more than 18 years\n* Aplastic anemia\n* Known hypersensitivity to romiplostim or any of its components","ALL","18 Years",{"count":32,"type":33},100,"ESTIMATED","OBSERVATIONAL","The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children",[37,38],"Romiplostim N01","ITP","NOT_YET_RECRUITING","2025-10-02",{"date":42,"type":43},"2025-10-09","ACTUAL",{"date":45,"type":33},"2025-11-01",{"date":47,"type":33},"2027-01-01",{"name":5,"class":6}]