[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653429":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":50,"studyPopulation":32,"armGroups":51,"interventions":69,"overallOfficials":87,"centralContacts":92,"locations":101,"responsibleParty":120,"collaborators":32,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":32,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":32,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":104,"whyStopped":32,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"sustained response rate","Defined as the proportion of patients who achieve a platelet count ≥30×10\\^9\u002FL at least 6 out of 12 scheduled visits during the 24 weeks following the core treatment period (weeks 13-36), in the absence of rescue therapy","between weeks 13 and 36",[14,18,22,26,30,34,38,41],{"measure":15,"description":16,"timeFrame":17},"time to response","The time from treatment initiation to achieve a complete response(platelet count ≥100 × 109\u002FL and absence of bleeding) or a partial response(platelet count ≥30 × 10\\^9\u002FL and at least 2-fold increase of the baseline platelet count and absence of bleeding)","in 0-12 weeks",{"measure":19,"description":20,"timeFrame":21},"Early response.","Proportion of patients achieving platelet count ≥30 × 10\\^9\u002FL and at least doubling baseline at 1 week after treatment initiation.","at 1 week",{"measure":23,"description":24,"timeFrame":25},"Initial response","Proportion of patients achieving platelet count ≥30 × 10\\^9\u002FL and at least doubling baseline at 1 month after treatment initiation.","at 1 month",{"measure":27,"description":28,"timeFrame":29},"overall response(OR) rate at week 12","Proportion of patients achieving complete response (CR) plus response (R) at Week 12","at week 12",{"measure":31,"description":32,"timeFrame":33},"Proportion of patients requiring rescue therapy",null,"in 0-36 weeks",{"measure":35,"description":36,"timeFrame":37},"bleeding scores","Assessed according to the WHO Bleeding Scale and the ITP Bleeding Scale","in 0-40 weeks",{"measure":39,"description":40,"timeFrame":37},"Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ)","In all participants ,use ITP-PAQ to assess the HRQoL before and after treatment.",{"measure":42,"description":43,"timeFrame":37},"Functional Assessment of 36-Item Short Form Survey (SF-36) scale","In all participants ,use SF-36 scale to assess the HRQoL before and after treatment.",{"allocation":45,"interventionModel":46,"interventionModelDescription":32,"primaryPurpose":47,"observationalModel":32,"timePerspective":32,"maskingInfo":48},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":49,"maskingDescription":32,"whoMasked":32},"NONE","The study will be conducted in three phases.\n\nPhase 1. Core treatment phase includes initial treatment and sequential combination therapy (12 weeks, weeks 1-12):\n\nPatients will receive standard-dose methylprednisolone or prednisone in combination with a thrombopoietin receptor agonist (TPO-RA) as initial therapy.Corticosteroids will be tapered and discontinued within 8 weeks; tapering will begin immediately in patients who achieve complete response (CR) and will also be initiated after 4 weeks in patients who do not achieve response (R). TPO-RA therapy will continue for 12 weeks, with dose adjustments made according to the approved prescribing information. Patients with treatment failure( defined as platelet count \\\u003C 30 × 10\\^9\u002FL or less than 2-fold increase of baseline platelet count or bleeding) after 2 weeks of initial therapy (Weeks 3-12) will receive the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody as sequential combination therapy.\n\nPhase 2. Core-treatment follow-up and exploratory treatment phase (24weeks, weeks 13-36):\n\nDuring the core treatment follow-up phase, patients with treatment failure will enter the exploratory treatment phase. Patients who did not receive rituximab or anti-CD38 monoclonal antibody during the core treatment phase will receive a switched TPO-RA combined with either rituximab or anti-CD38 monoclonal antibody, whereas patients who received either rituximab or anti-CD38 monoclonal antibody during the core phase will receive a switched TPO-RA combined with cross-administered rituximab and anti-CD38 monoclonal antibody.TPO-RA therapy will also continue for 12 weeks.\n\nPhase3. Safety follow-up phase (4weeks,weeks 37-40).\n\nRescue therapy includes, but is not limited to, intravenous immunoglobulin (IVIG), platelet transfusion, and vindesine. A switch to another thrombopoietin receptor agonist (TPO-RA) will be considered rescue therapy during the core treatment period. Administration of recombinant human thrombopoietin (rhTPO) will also be considered rescue therapy.",[52,59,65],{"label":53,"type":54,"description":55,"interventionNames":56},"Initial therapy","EXPERIMENTAL","standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA)",[57,58],"Drug: standard-dose methylprednisolone\u002Fprednisone.","Drug: thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag.",{"label":60,"type":54,"description":61,"interventionNames":62},"Sequential Combination Therapy","the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody（mAb）",[58,63,64],"Drug: rituximab.","Drug: Daratumumab",{"label":66,"type":54,"description":67,"interventionNames":68},"Exploratory treatment","a switched TPO-RA combined with either rituximab or anti-CD38 monoclonal antibody",[58,63,64],[70,75,79,83],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":32},"DRUG","standard-dose methylprednisolone\u002Fprednisone.","Methylprednisolone 0.8-1mg\u002Fkg\u002Fday administered intravenously or orally; or prednisone 1 mg\u002Fkg\u002Fday, up to a maximum dose of 80 mg\u002Fday",[53],{"type":71,"name":76,"description":77,"armGroupLabels":78,"otherNames":32},"thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag.","Dosing will follow the recommended dose in the prescribing information; in severe ITP, the initial dose will be selected according to BAT (best available therapy) principles.",[66,53,60],{"type":71,"name":80,"description":81,"armGroupLabels":82,"otherNames":32},"rituximab.","Administered as 375 mg\u002Fm² by intravenous infusion for a single dose, or 100 mg by intravenous infusion once weekly for a total of 4 doses.",[66,60],{"type":71,"name":84,"description":85,"armGroupLabels":86,"otherNames":32},"Daratumumab","Administered at 16 mg\u002Fkg by intravenous infusion once weekly for a total of 4-8 doses.",[66,60],[88],{"name":89,"affiliation":90,"role":91},"Lei Zhang","Thrombosis and Haemostasis Diagnosis Treatment Center","STUDY_DIRECTOR",[93,98],{"name":94,"role":95,"phone":96,"phoneExt":32,"email":97},"Xiaofan Liu","CONTACT","+86-022-23608180","liuxiaofan@ihcams.ac.cn",{"name":99,"role":95,"phone":32,"phoneExt":32,"email":100},"Rongfeng Fu","furongfeng@ihcams.ac.cn",[102],{"facility":103,"status":104,"city":105,"state":32,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Ethics Committee of Hematology Hospital, Chinese Academy of Medical Sciences","RECRUITING","Tianjin","300020","China","CN",{"type":110,"coordinates":111},"Point",[112,113],117.17667,39.14222,{"lat":113,"lon":112},[116],{"name":117,"role":95,"phone":118,"phoneExt":32,"email":119},"Shuo Chen","+86-022-23608025","ec@ihcams.ac.cn",{"type":121,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100653429","phase-4-multi-target-drugs-sequential-combination-therapy-in-adults-patients-with-newly-diagnosed-primary-immune-thrombocytopenia-100653429",false,"NCT07788456","Multi-target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia","Efficacy and Safety of Multi-Target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia: A Prospective, Single-arm, Multicenter, Exploratory Trial","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Confirmed newly diagnosed primary ITP with a platelet count \\\u003C30 × 10\\^9\u002FL.\n3. No prior ITP-related treatment before enrollment, except for standard-dose corticosteroids and\u002For IVIG for ≤5 days.\n4. Able to understand the study and provide signed informed consent.-\n\nExclusion Criteria:\n\n1. Use of corticosteroids or immunosuppressants for a non-ITP condition within 3 months.\n2. Contraindication to corticosteroid therapy.\n3. Arterial or venous thromboembolic event within 3 months.\n4. Pregnant or breastfeeding women.\n5. Current treatment with another investigational drug.\n6. Any other medical history or condition that, in the investigator's judgment, makes the participant unsuitable for the study.\n\n   \\-","ALL","18 Years","75 Years",{"count":133,"type":134},38,"ESTIMATED","INTERVENTIONAL",[137],"PHASE4","This prospective, single-arm, multicenter, exploratory study will enroll 38 adults patients with newly diagnosed primary immune thrombocytopenia (ITP). Patients will receive standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA) as initial therapy During the core treatment phase (Weeks 1-12). Corticosteroids will be tapered and discontinued within 8 weeks, whereas TPO-RA treatment will continue for 12 weeks. For patients with treatment failure( defined as platelet count \\\u003C 30 × 10\\^9\u002FL or less than 2-fold increase of baseline platelet count or bleeding) ,a sequential multitarget combination strategy will be explored in subsequent treatment phases. Specifically, patients with treatment failure after 2 weeks of initial therapy (Weeks 3-12), will receive the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody（mAb） as sequential combination therapy.\n\nDuring the core treatment follow-up phase (24 weeks), patients with treatment failure will enter the exploratory treatment phase (Weeks 13-36) .\n\nPatients who received multi-target drug therapy during the core treatment period will switch to an alternative TPO-RA with cross-administered rituximab and anti-CD38 mAb, while those who did not will receive sequential rituximab or anti-CD38 mAb.\n\nFinally, patients will enter the safety follow up period (4 weeks, weeks 37-40).",[140],"ITP - Immune Thrombocytopenia",[142,143],"corticosteroid","thrombopoietin receptor agonist （TPO-RA）","2026-08-24",{"date":146,"type":147},"2026-08-26","ACTUAL",{"date":149,"type":147},"2026-06-22",{"date":151,"type":134},"2027-06-30",{"name":5,"class":6},1]