[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523376":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention (Obinutuzumab)","EXPERIMENTAL","60 enrolled subjects: one infusion",[13],"Drug: Obinutuzumab Injection [Gazyva]",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Obinutuzumab Injection [Gazyva]","intravenous Obinutuzumab administration\n\nThis study adopts a prospective, single arm, open design method. 60 subjects were enrolled in the study and were treated with CD20 monoclonal antibody (Obinutuzumab: 1000mg) for once.\n\nThe first stage is the main research stage (d1-w12), which is the core treatment period. The subjects will receive intravenous infusion of 1000mg Obinutuzumab for once to observe the safety and efficacy during treatment.\n\nThe second stage (w12-w48) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Obinutuzumab after treatment.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Lei Zhang, MD","Chinese Academy of Medical Science and Blood Disease Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Ting Sun, MD","CONTACT","+8615822339131","sunting@ihcams.ac.cn",[33],{"facility":34,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Tianjin","China","CN",{"type":40,"coordinates":41},"Point",[42,43],117.17667,39.14222,{"lat":43,"lon":42},[46,47],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100523376","phase-2-a-prospective-one-arm-and-open-clinical-study-of-obinutuzumab-in-the-treatment-of-pediatric-primary-immune-thrombocytopenia-itp-100523376",false,"NCT06094881","A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-Human CD20 Monoclonal Antibody Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age 12-18 years old, male or female\n* Conform to the diagnostic criteria of persistent or chronic immune Thrombocytopenia (ITP)\n* With a platelet count of \\\u003C30 X 10\\^9\u002FL measured within 2 days prior to administration（Platelet counts were measured at least 2 times during screening (at least 1 week apart) with platelets\\\u003C30 X 10\\^9\u002FL）\n* Failure or recurrence of previous hormonal therapy or hormone dependence\n* The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration\n* Signed and dated written informed consent\n* With Liver and kidney function\\\u003C1.5×upper limit of normal， such as ALT、AST，BUN，Cre，etc.\n* ECOG physical state score ≤ 2 points\n* Cardiac function of the New York Society of Cardiac Function ≤ 2\n* Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg\u002Fkg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\\>3 months；More than 6 months after splenectomy.\n\nExclusion Criteria:\n\n* Subjects with primary disease of important organs (liver, kidney, heart, etc.), or with immune system diseases;\n* Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.;\n* Subjects infected with human immunodeficiency virus (HIV);\n* Uncontrollable or active infections during the screening period, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or positive syphilis antigen;\n* Subjects with extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage;\n* Subjects with heart disease that requires treatment or hypertension that has been judged by researchers to be poorly controlled currently;\n* Subjects with any venous or arterial thrombosis, atherosclerosis, and other diseases;\n* Subjects with a history of malignant solid tumor or have received allogeneic stem cell transplantation or organ transplantation;\n* Subjects with mental disorders who are unable to sign normal informed consent and conduct trials and follow-up;\n* Subjects whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Subjects with other serious diseases that may limit their participation in this trial (diabetes; severe cardiac insufficiency; myocardial obstruction or unstable arrhythmia or unstable angina pectoris in the last 6 months; gastric ulcer; active autoimmune disease, etc.);\n* Subjects with septicemia or other irregular bleeding;\n* Patients taking antiplatelet drugs at the same time;\n* Any medical history or condition that the investigator deems unsuitable for participation in the study.","ALL","12 Years","18 Years",{"count":61,"type":62},60,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","To evaluate the safety and efficacy of Obinutuzumab in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line glucocorticoid treatment.",[68,69],"Immune Thrombocytopenia","Treatment","2025-02-20",{"date":72,"type":73},"2025-02-24","ACTUAL",{"date":75,"type":73},"2023-12-01",{"date":77,"type":62},"2026-11",{"name":5,"class":6},1]