[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612596":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":11,"studyPopulation":58,"armGroups":59,"interventions":65,"overallOfficials":11,"centralContacts":73,"locations":79,"responsibleParty":156,"collaborators":11,"id":158,"slug":11,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":11,"eligibilityCriteria":163,"healthyVolunteers":159,"sex":164,"minAge":165,"maxAge":11,"enrollmentInfo":166,"targetDuration":11,"studyType":169,"phases":11,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":82,"whyStopped":11,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Blueprint Medicines Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Mastocytosis Control-quality of Life (MC-QoL) Questionnaire Score at Month 6",null,"Baseline, Month 6",[14,17,19,21,23,25,27,30,32,34,37,39,41,43,45,47,49,51,53],{"measure":15,"description":11,"timeFrame":16},"Socio-demographic Variable: Participant Age","Baseline (Day -30 to Day -1)",{"measure":18,"description":11,"timeFrame":16},"Socio-demographic Variable: Participant Gender",{"measure":20,"description":11,"timeFrame":16},"Socio-demographic Variable: Participant Ethnicity",{"measure":22,"description":11,"timeFrame":16},"Socio-demographic Variable: Participant Race",{"measure":24,"description":11,"timeFrame":16},"Baseline Serum Tryptase and KIT D816V Variant Allele Fraction (VAF)",{"measure":26,"description":11,"timeFrame":16},"Number of Participants With Prior Medical History of Anaphylaxis",{"measure":28,"description":11,"timeFrame":29},"Number of Participants with Comorbidity","Baseline up to Month 24",{"measure":31,"description":11,"timeFrame":29},"Number of Participants Initiating a New ISM-directed Medication, Discontinuing an ISM-directed Medication, and With Dose Increases or Decreases for ISM-directed Medications",{"measure":33,"description":11,"timeFrame":29},"Number of Participants Prescribed a Life Support Kit",{"measure":35,"description":11,"timeFrame":36},"Change From Baseline in Mastocytosis Activity Score (MAS) at Months 3, 6, 12, 18, and 24","Baseline, Months 3, 6, 12, 18, and 24",{"measure":38,"description":11,"timeFrame":36},"Change From Baseline in MC-QoL Questionnaire Score at Months 3, 6, 12, 18, and 24",{"measure":40,"description":11,"timeFrame":36},"Change From Baseline in Mastocytosis Control Test (MCT) Score at Months 3, 6, 12, 18, and 24",{"measure":42,"description":11,"timeFrame":29},"Time to Response as Assessed by MAS",{"measure":44,"description":11,"timeFrame":36},"Change From Baseline in Serum Tryptase at Months 3, 6, 12, 18, and 24",{"measure":46,"description":11,"timeFrame":29},"Number of Participants With Anaphylaxis Requiring Hospitalization, Emergency Room (ER) Visit, Epinephrine Autoinjector Use, or Other Medication",{"measure":48,"description":11,"timeFrame":29},"Number of Participants Meeting the Definition of Polypharmacy (Use of Multiple Medications Simultaneously; Typically, 3 or More Symptom-directed Prescription Drugs)",{"measure":50,"description":11,"timeFrame":29},"Number of Participants With ISM-related Hospital Visits and ER Visits",{"measure":52,"description":11,"timeFrame":29},"Number of Participants With Changes in ISM Symptom-directed Therapies",{"measure":54,"description":11,"timeFrame":29},"Number of Participants With Dose Modifications and Study\u002FTreatment Discontinuations",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":56,"timePerspective":57,"maskingInfo":11},"OTHER","PROSPECTIVE","Adult participants with ISM with moderate to severe symptoms inadequately controlled on symptomatic treatment, who are initiating treatment with commercial avapritinib according to the German approved label.",[60],{"label":61,"type":11,"description":62,"interventionNames":63},"Avapritinib","Participants will receive avapritinib as part of their treatment plan with their healthcare practitioner (HCP) and in accordance with the Summary of Product Characteristics (SmPC).",[64],"Drug: Avapritinib",[66],{"type":67,"name":61,"description":68,"armGroupLabels":69,"otherNames":70},"DRUG","Avapritinib will be administered as an oral tablet.",[61],[71,72],"Ayvakyt","BLU-285",[74],{"name":75,"role":76,"phone":77,"phoneExt":11,"email":78},"Blueprint Medicines, EU Contact","CONTACT","+31 85 064 4001","medinfoeurope@blueprintmedicines.com",[80,93,102,111,120,129,138,147],{"facility":81,"status":82,"city":83,"state":11,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":11},"Charité Universitätmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie","RECRUITING","Berlin","10117","Germany","DE",{"type":88,"coordinates":89},"Point",[90,91],13.41053,52.52437,{"lat":91,"lon":90},{"facility":94,"status":82,"city":95,"state":11,"zip":96,"country":85,"countryCode":86,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"Katholisches Klinikum Bochum","Bochum","44791",{"type":88,"coordinates":98},[99,100],7.21648,51.48165,{"lat":100,"lon":99},{"facility":103,"status":82,"city":104,"state":11,"zip":105,"country":85,"countryCode":86,"cosmosGeoPoint":106,"geoPoint":110,"contacts":11},"MVZ Klinikum Deggendorf","Deggendorf","94469",{"type":88,"coordinates":107},[108,109],12.96068,48.84085,{"lat":109,"lon":108},{"facility":112,"status":82,"city":113,"state":11,"zip":114,"country":85,"countryCode":86,"cosmosGeoPoint":115,"geoPoint":119,"contacts":11},"Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie","Dresden","01307",{"type":88,"coordinates":116},[117,118],13.73832,51.05089,{"lat":118,"lon":117},{"facility":121,"status":82,"city":122,"state":11,"zip":123,"country":85,"countryCode":86,"cosmosGeoPoint":124,"geoPoint":128,"contacts":11},"University Medical Center Goettingen - Georg August University of Goettingen","Göttingen","37075",{"type":88,"coordinates":125},[126,127],9.93228,51.53443,{"lat":127,"lon":126},{"facility":130,"status":82,"city":131,"state":11,"zip":132,"country":85,"countryCode":86,"cosmosGeoPoint":133,"geoPoint":137,"contacts":11},"Universitats-Hautklinik Tubingen, Studienzentrum lmmundermatologie","Tübingen","72076",{"type":88,"coordinates":134},[135,136],9.05222,48.52266,{"lat":136,"lon":135},{"facility":139,"status":82,"city":140,"state":11,"zip":141,"country":85,"countryCode":86,"cosmosGeoPoint":142,"geoPoint":146,"contacts":11},"HNO-Gemeinschaftspraxis Wiesbaden, GEKA Gesellschaft für Experimentelle und Klinische Atemwegsforschung mbH, Zentrum für Rhinologie und Allergologie","Wiesbaden","65205",{"type":88,"coordinates":143},[144,145],8.24435,50.08601,{"lat":145,"lon":144},{"facility":148,"status":82,"city":149,"state":11,"zip":150,"country":85,"countryCode":86,"cosmosGeoPoint":151,"geoPoint":155,"contacts":11},"Helios Universitätsklinikum Wuppertal","Wuppertal","42283",{"type":88,"coordinates":152},[153,154],7.14816,51.25627,{"lat":154,"lon":153},{"type":157,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100612596",false,"NCT07255638","A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany","A Prospective Non-Interventional Study to Describe the Effectiveness of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Patients With Indolent Systemic Mastocytosis and Symptoms That Are Not Adequately Controlled With Symptomatic Treatments in Real-World Settings","Inclusion Criteria:\n\n* Participants is starting avapritinib treatment at the HCP's discretion as part of their routine care (for ISM with moderate to severe symptoms inadequately controlled with symptomatic treatment) and in accordance with approved SmPC.\n\nExclusion Criteria:\n\n* Participant with a potential increased risk for intracranial hemorrhage including those with a history of vascular aneurysm, intracranial hemorrhage, cerebrovascular accident within the prior year, or severe thrombocytopenia.\n* Participant who has previously taken avapritinib as a commercial drug or as part of a clinical study.","ALL","18 Years",{"count":167,"type":168},80,"ESTIMATED","OBSERVATIONAL","This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany. The study also seeks to address the existing data gap in the natural history and management of participants with ISM.\n\nThe study is designed to follow each participant up to a maximum of 24 months.",[172],"Indolent Systemic Mastocytosis",[174,175,61,72,176,177,178,179],"ISM","Indolent systemic mastocytosis","Selective KIT mutation-targeted tyrosine kinase inhibitor","Tyrosine kinase inhibitor","Mastocytosis","Neoplastic mast cells","2026-04-17",{"date":182,"type":183},"2026-04-20","ACTUAL",{"date":185,"type":183},"2025-12-09",{"date":187,"type":168},"2028-12-01",{"name":5,"class":6},8]