[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100257168":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":10,"locations":33,"responsibleParty":91,"collaborators":10,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":10,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":10,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":119,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Celgene","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"β-thalassemia transfusion dependent subjects",null,"Participants will complete 3 quality of life instruments (i.e. FACT-AN, the SF-36v2, and the TranQol) once every 3 weeks, in addition to a TranQol instrument on the day of a RBC transfusion. Continuous monitoring of Healthcare Resource Utilization will be conducted throughout the course of the study at each clinical visit.",[13,14],"Other: Quality of Life (QOL) questionnaires","Other: Healthcare Resource Utilization",{"label":16,"type":10,"description":17,"interventionNames":18},"β-thalassemia Non Transfusion Dependent (NTD) subjects","Participants will complete 2 quality of life instruments (i.e. FACT-An and the the SF-36v2l) once every 3 weeks, in addition to completing the non-transfusion dependent Patient Recorded Outcome (PRO) tool on a daily basis. Continuous monitoring of Healthcare Resource Utilization will be conducted throughout the course of the study at each clinical visit.",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"OTHER","Quality of Life (QOL) questionnaires","Monitoring of FACT-AN, SF-36V2, TransQol, and NTD PRO assessments,",[16,9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Healthcare Resource Utilization","Monitoring and reviewing HealthCare Resource Utilization information.",[16,9],[30],{"name":31,"affiliation":5,"role":32},"Xiaohan (Henry) HU, MD, MPH, PhD","STUDY_DIRECTOR",[34,47,58,69,81],{"facility":35,"status":10,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"Aghia Sofia Children's Hosptial","Athens","Goudi","11527","Greece","GR",{"type":42,"coordinates":43},"Point",[44,45],23.72784,37.98376,{"lat":45,"lon":44},{"facility":48,"status":10,"city":49,"state":10,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":10},"Fondazione IRCCS Ca Granda Ospedale Maggiore","Milan","20122","Italy","IT",{"type":42,"coordinates":54},[55,56],12.59836,42.78235,{"lat":56,"lon":55},{"facility":59,"status":10,"city":60,"state":10,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"American University of Beirut Medical Center","Beirut","4407 2020","Lebanon","LB",{"type":42,"coordinates":65},[66,67],35.50157,33.89332,{"lat":67,"lon":66},{"facility":70,"status":10,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":10},"Faculty of Medicine Siriraj Hospital, Mahidol University","Bangkok","Bangkoknoi","10700","Thailand","TH",{"type":42,"coordinates":77},[78,79],100.50144,13.75398,{"lat":79,"lon":78},{"facility":82,"status":10,"city":83,"state":10,"zip":84,"country":85,"countryCode":10,"cosmosGeoPoint":86,"geoPoint":90,"contacts":10},"Cukurova University Medical Faculty Balcali Hospital","Çukurova","1330","Turkey (Türkiye)",{"type":42,"coordinates":87},[88,89],28.18319,38.46967,{"lat":89,"lon":88},{"type":92,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100257168","to-document-the-burden-of-illness-on-the-quality-of-life-and-the-impact-on-healthcare-utilization-in-beta--thalassemia-subjects-who-are-transfusion-dependent-td-and-non-transfusion-dependent-ntd-receiving-standard-of-care-100257168",false,"NCT02626689","To Document the Burden of Illness on the Quality of Life and the Impact on Healthcare Utilization in (Beta) β-thalassemia Subjects Who Are Transfusion Dependent (TD) and Non-transfusion Dependent (NTD) Receiving Standard of Care","Burden of Beta-Thalassemia - Quality of Life and Health Care Resource Utilization- A Prospective Observational Study","Inclusion Criteria:\n\nFor the transfusion dependent (TD) subjects:\n\n1. Male or female, \\>18 years of age at the time of signing the informed consent document (ICF);\n2. Documented diagnosis of β-thalassemia or hemoglobin E\u002F β-thalassemia;\n3. TD - defined as: ≥6 Red Blood Cells (RBC) units in the 24 weeks prior to study participation and no transfusion free period for ≥35 days during that period; and\n4. Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n\nFor the non-transfusion dependent (NTD) subpopulation\n\n1. Male or female, \\>18 years of age at the time of signing the informed consent document (ICF).\n2. Documented diagnosis of β-thalassemia or hemoglobin E\u002F β-thalassemia\n3. NTD - defined as: 0 to 5 RBC units received during the 24-week period prior to study participation (not including RBC transfusions units administered for elective surgery);\n4. Most recent hemoglobin ≤10 g\u002FdL (hemoglobin values ≤ 21 days post-transfusion will be excluded)\n5. Performance status: ECOG score of 0 to 1.\n\nExclusion Criteria:\n\nFor TD Subpopulation:\n\n1. A diagnosis of hemoglobin S\u002Fβ-thalassemia;\n2. Any significant psychiatric or medical conditions not related to thalassemia that would prevent the subject from participating in the study;\n3. Inability to read or understand the local official languages; or\n4. Participated in another clinical trial (interventional) \\\u003C30 days prior to study participation\n\nFor NTD Subpopulation:\n\n1. Received RBC transfusion ≤ 8 weeks prior to study enrollment;\n2. A diagnosis of hemoglobin S\u002Fβ-thalassemia;\n3. Any significant psychiatric or medical conditions not related to thalassemia that would prevent the subject from participating in the study;\n4. Inability to read or understand the local official languages; or\n5. Participated in another clinical trial (interventional) \\\u003C30 days prior to study participation.","ALL","18 Years",{"count":103,"type":104},100,"ACTUAL","OBSERVATIONAL","This is a multi-site, prospective, observational study implemented in β-thalassemia treatment centers from 5 countries (Italy, Turkey, Greece, Lebanon, and Thailand). Approximately one to two study sites will be identified per country and approximately 20 β-thalassemia subjects will be enrolled per country (10 transfusion dependent (TD) and 10 Non-transfusion dependent (NTD) with a total of approximately 100 subjects. This study will not interfere with or influence the routine clinical management of β-thalassemia patients. Outcomes of interest will be collected prospectively for up to 6 months.",[108],"Beta-Thalassemia",[108,110,111,112,113,114,115,116,117,118],"Quality of Life","Healthcare Utilization","Transfusion dependent (TD) β-thalassemia","Non-transfusion dependent β-thalassemia","Standard of care","TransQoL","SF36v2","Fact-An","NTD beta-thalassemia PRO","COMPLETED","2017-04-06",{"date":122,"type":104},"2017-04-07",{"date":124,"type":104},"2016-03-01",{"date":126,"type":104},"2017-01-03",{"name":5,"class":6},5]