[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"house-dust-mite-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:house-dust-mite-allergy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100469659","phase-3-efficacy-and-safety-assessment-of-beltavac-with-polymerized-extract-of-hdm-100469659",false,"NCT05395689","Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM","Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis\u002FRhinoconjuntivitis","PROACAROS","Inclusion Criteria:\n\n* Written informed consent, signed and duly dated.\n* Man or woman between 12 and 65 years old (both included).\n* Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.\n* Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (\\> 3.5 kU \u002F L) within the 6 months prior to the study.\n* Negative pregnancy test.\n* Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.\n\nExclusion Criteria:\n\n* Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.\n* Poorly controlled asthma according to the GEMA 5.0 guideline\n* Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.\n* Autoimmune diseases or immunodeficiency.\n* Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.\n* Clinical history of anaphylaxis with cardio \u002F respiratory symptoms.\n* Hypersensitivity to any of the excipients of the investigational product.\n* Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study.\n* Treatment with beta-blockers during the study.\n* Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years.\n* Patients with immunotherapy with allergens other than dust mites during the study period.\n* Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-19.\n* Pregnant or nursing patients.","ALL","12 Years","65 Years",{"count":21,"type":22},350,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma",[28],"House Dust Mite Allergy","RECRUITING","2024-07-17",{"date":32,"type":33},"2024-07-18","ACTUAL",{"date":35,"type":33},"2022-01-17",{"date":37,"type":22},"2026-06",{"name":39,"class":40},"Probelte Pharma S.L.U.","INDUSTRY",18]