[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632458":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":27,"armGroups":28,"interventions":22,"overallOfficials":22,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":22,"id":57,"slug":22,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":22,"studyType":70,"phases":22,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":41,"whyStopped":22,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of responders to daratumumab","Number of patients responding to daratumumab \u002F total number of patients treated with daratumumab (response defined as the achievement of ADAMTS13 activity levels above 20% of normal at any timepoint from the first daratumumab administration to 12 weeks after the last dose, without new additional immunosuppressants)","From the first daratumumab administration to 12 weeks after the last dose",[14,18],{"measure":15,"description":16,"timeFrame":17},"Safety of daratumumab","Number of adverse events related to daratumumab, using CTCAE v5.0","From the first daratumumab administration to 24 weeks after",{"measure":19,"description":20,"timeFrame":21},"Duration of response","Median ADAMTS13 relapse-free survival after daratumumab treatment","From the date of the first documented ADAMTS13 activity >20% after the first dose of daratumumab until the date of ADAMTS13 relapse (i.e., ADAMTS13 activity \u003C20%), assessed up to 3 years.",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":24,"timePerspective":25,"maskingInfo":22},"CASE_ONLY","RETROSPECTIVE","iTTP in an autoimmune disease caused by autoantibodies directed against the metalloproteinase ADAMTS13. Rituximab is the standard immune suppressive treatment suggested from international guidelines. However, 10-15% of patients do not achieve a sustained ADAMTS13 remission with rituximab, and a significant portion of responders eventually need re-treatment after 12 months or less. Other therapeutic options are scarce and based on old immunosuppressive agents or splenectomy, all burdened by relevant toxicity and lack of solid efficacy data. Recently, targeting CD20-negative long-lived plasma cells appears to be a promising strategy in refractory iTTP. The anti-CD38 monoclonal antibody daratumumab has been employed in selected iTTP patients with good results. However, evidence stems only from isolated case reports.\n\nThe DarTTP study aims to collect evidence on a larger number of patients about the efficacy and safety of daratumumab in iTTP subjects who are refractory or intolerant to previous immunosuppressive treatments. The primary endpoint is the proportion of patients with ADAMTS13 activity levels above 20% of normal at 6 months from the first daratumumab administration.","The study includes adult iTTP patients who were treated with daratumumab in the acute phase of disease (i.e., with plasma exchanges and\u002For caplacizumab ongoing) or during remission (i.e., due to ADAMTS13 relapse or ADAMTS13 activity plasma levels persistently \\\u003C20%) from January 2010 to 6 months before the time of data collection. It includes iTTP patients receiving daratumumab either for refractory disease or in ADAMTS13 remission but intolerant to other immune suppressive agents.",[29],{"label":30,"type":22,"description":31,"interventionNames":22},"Adult patients with iTTP","Patients with a confirmed diagnosis of iTTP, aged ≥ 18 years, treated with daratumumab for iTTP",[33],{"name":34,"role":35,"phone":36,"phoneExt":22,"email":37},"Juri A Giannotta, M.D.","CONTACT","+390255035273","juri.giannotta@policlinico.mi.it",[39],{"facility":40,"status":41,"city":42,"state":22,"zip":22,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Angelo Bianchi Bonomi Hemophilia and Thrombosis Center","RECRUITING","Milan","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],12.59836,42.78235,{"lat":49,"lon":48},[52,53],{"name":34,"role":35,"phone":36,"phoneExt":22,"email":37},{"name":34,"role":54,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100632458",false,"NCT07513948","Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura","DarTTP: an Observational, International, Multicentric Study on Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)","DarTTP","Inclusion Criteria:\n\n* patients with a confirmed diagnosis of iTTP (i.e., ADAMTS13 activity \\\u003C10% with anti-ADAMTS13 antibodies detected);\n* aged ≥ 18 years;\n* male and female patients;\n* treated with daratumumab for iTTP.\n\nExclusion Criteria:\n\n* patients unwilling or unable to provide their informed consent;\n* follow-up \\\u003C 6 months after daratumumab administration.","ALL","18 Years","99 Years",{"count":68,"type":69},40,"ESTIMATED","OBSERVATIONAL","Data about efficacy and safety of daratumumab in iTTP refractory or intolerant to standard immunosuppressive treatments are scarce. Therefore, the investigators aim at collecting evidence on a larger number of patients through a collaborative, international study.",[73],"Thrombotic Thrombocytopenic Purpura, Acquired",[75,76,77],"daratumumab","thrombotic thrombocytopenic purpura","ADAMTS13","2026-04-13",{"date":80,"type":81},"2026-04-14","ACTUAL",{"date":83,"type":81},"2025-10-01",{"date":85,"type":69},"2026-08",{"name":5,"class":6},1]