[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"platelet-transfusion-refractoriness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:platelet-transfusion-refractoriness":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100576955","phase-1-study-of-cm313sc-injection-in-subjects-with-platelet-transfusion-refractoriness-100576955",false,"NCT06792019","Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness","A Phase IB\u002FII Clinical Study to Assess the Safety and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness","Inclusion Criteria:\n\n1. Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.\n2. Presence of one or more kinds of antiplatelet antibodies.\n3. Male or female, age≥18 years.\n4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.\n5. Willing and able to comply with the requirements for this study and written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with Idiopathic thrombocytopenic purpura.\n2. Platelet transfusion refractoriness caused by non-immune factors.\n3. Previously treated with the anti-CD38 monoclonal antibody.\n4. Have an allergy to humanized monoclonal antibody or any part of CM313.\n5. Pregnant or breastfeeding females, or females planning to become pregnant during the study.\n6. Any condition considered to be ineligible for the study by the investigator.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a randomized, open-label, phase IB\u002FII clinical study to evaluate the safety and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness.",[27],"Platelet Transfusion Refractoriness","RECRUITING","2025-08-11",{"date":31,"type":32},"2025-08-15","ACTUAL",{"date":34,"type":32},"2025-03-25",{"date":36,"type":20},"2027-11-16",{"name":38,"class":39},"Keymed Biosciences Co.Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100535648","phase-2-rituximab-for-serious-aplastic-anemia-with-platelet-transfusion-refractoriness-100535648","NCT06254560","Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness","The Study of Rituximab in the Treatment of Severe Aplastic Anemia With Platelet Transfusion Refractoriness","Inclusion Criteria:\n\n* Initial diagnosed SAA with PTR\n* Age\\>18 years old, regardless of gender\n* Initial diagnosed SAA with PTR\n* Age\\>18 years old, regardless of gender\n\nExclusion Criteria:\n\n* Allergy to rituximab\n* Severe active infection\n* Hypogammaglobulinemia\n* Pregnant and lactating women\n* Heart failure (NYHA classification IV)\n* Individuals with epilepsy, dementia, and other mental disorders that require medication treatment who cannot understand or follow the research protocol\n* Chronic infections or other chronic diseases that may be risk to the experiment\n* The researchers believe that it is not suitable for participants","70 Years",{"count":50,"type":20},20,[24],"Due to long-term dependence on platelet transfusion, some severe aplastic anemia (SAA) patients suffer platelet transfusion refractoriness (PTR). Unlike immune thrombocytopenia (ITP), glucocorticoids and human immunoglobulin (IVIg) are generally ineffective for PTR. Due to the lack of effective intervention methods, patients with PTR suffer increased platelet transfusions, bleeding events and treatment costs, prolonged hospital stays, and decreased survival rate. SAA with PTR has become a challenge for physicians. The experiment aims to explore the efficacy of rituximab in the treatment of SAA with PTR, and establish a new effective, safe treatment method with relatively low treatment cost.",[54,27],"Severe Aplastic Anemia",[56,57,58],"Severe aplastic anemia","Platelet transfusion refractoriness","Rituximab","2024-02-03",{"date":61,"type":32},"2024-02-12",{"date":63,"type":32},"2023-02-23",{"date":65,"type":20},"2027-12-30",{"name":67,"class":68},"Institute of Hematology & Blood Diseases Hospital, China","OTHER"]