[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574840":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":17,"responsibleParty":31,"collaborators":7,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":7,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":7,"enrollmentInfo":42,"targetDuration":7,"studyType":45,"phases":7,"briefSummary":46,"conditions":47,"keywords":7,"overallStatus":20,"whyStopped":7,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":58},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",null,[9],{"name":10,"affiliation":5,"role":11},"Stefania Paolini, MD","PRINCIPAL_INVESTIGATOR",[13],{"name":10,"role":14,"phone":15,"phoneExt":7,"email":16},"CONTACT","+390512143680","stefania.paolini@unibo.it",[18],{"facility":19,"status":20,"city":21,"state":7,"zip":22,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":7},"IRCCS Azienda Ospedaliera -Universitaria di Bologna","RECRUITING","Bologna","40138","Italy","IT",{"type":26,"coordinates":27},"Point",[28,29],11.33875,44.49381,{"lat":29,"lon":28},{"type":32,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100574840","evaluation-of-response-to-biosimilar-erythropoietin-alfa-therapy-in-anemic-patients-with-myelodysplastic-syndrome-100574840",false,"NCT06764511","Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome","Valutazione Della Risposta Alla Terapia Con Eritropoietina Alfa Biosimilare Nei Pazienti Anemici Affetti da Sindrome Mielodisplastica","Inclusion Criteria:\n\nMDS patients with symptomatic anemia (pre-treatment hemoglobin \\\u003C 10g\u002FdL) who started treatment with biosimilar EPO alpha, diagnosed according to the WHO 2016 classification, and characterized by very low, low, or intermediate IPSS-R risk and a pre-treatment serum EPO level \\\u003C 500 U\u002FL, who started treatment with biosimilar EPO alpha at the U. O. of Hematology of IRCCS AOUBO during the period from 01\u002F06\u002F2018 to 31\u002F12\u002F2021.\n\n* Age ≥ 18 years at the time of enrollment\n* Acquisition of informed consent to study participation and data processing\n\nExclusion Criteria:\n\n* \\- Presence of other possible contributory causes of anemia (e.g., anemia from chronic inflammatory disease, hemolysis, hemorrhage)\n* Poor compliance with treatment\n* Very impaired general clinical condition (ECOG performance status \\> 3)\n* Concomitant treatment with antineoplastic cytotoxic drugs","ALL","18 Years",{"count":43,"type":44},60,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to describe the response to treatment with biosimilar EPO alpha in MDS patients who had already been treated with \"originator\" EPO alpha and were responsive, and in patients who started treatment with biosimilar EPO alpha",[48],"Myelodysplastic Syndromes (MDS)","2025-01-02",{"date":51,"type":52},"2025-01-08","ACTUAL",{"date":54,"type":52},"2024-08-30",{"date":56,"type":44},"2025-04-30",{"name":5,"class":6},1]