[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Probelte Pharma S.L.U.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100616762","study-to-assess-the-safety-and-effectiveness-of-beltaven-in-patients-with-allergy-to-apis-mellifera-polistes-dominula-or-vespula-spp-100616762",false,"NCT07309822","Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.","Observational Prospective Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp","Inclusion Criteria:\n\n* Age 14 years or older at the time of study inclusion.\n* Written informed consent, duly signed and dated by the patient or by the legal representative in the case of minors.\n* Assent form duly signed and dated by the minor, when applicable.\n* Patients with allergy to Apis mellifera, Vespula spp., or Polistes dominula who have experienced a systemic reaction following a hymenoptera sting, either with involvement of multiple organs or exclusively cutaneous.\n* Positive intradermal test (mean wheal diameter ≥ 5 mm) with Beltaven® diagnostic (allergenic extract of Apis mellifera, Vespula spp., or Polistes dominula).\n* Positive specific IgE test from class 1 onwards (≥ 0.35 kUA\u002FL).\n* Patients willing to receive immunotherapy with Beltaven®.\n\nExclusion Criteria:\n\n* Patients with severe cardiovascular diseases, active malignant neoplasms or malignancies in remission within the last 5 years, non-stabilized systemic or organ-specific autoimmune diseases, severe mental disorders, or other relevant chronic diseases that may interfere with the study results.\n* Patients with known allergy to any of the vaccine excipients.\n* Pregnant patients, patients planning to become pregnant during the study period, or breastfeeding patients.\n* Patients who have received hymenoptera immunotherapy within the 5 years prior to inclusion or during the study.\n* Patients who are to receive immunotherapy with another specific allergen different from the investigational treatment during the study period.\n* Patients with confirmed sensitization to two or more hymenoptera species as demonstrated by CAP inhibition testing.\n* Patients with thrombocytopenic purpura and vasculitis, rhabdomyolysis, or renal failure.","ALL","14 Years",{"count":19,"type":20},27,"ESTIMATED","OBSERVATIONAL","Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltaven® With Apis mellifera, Polistes dominula or Vespula spp. allergic patients",[24],"Allergy","RECRUITING","2025-12-16",{"date":28,"type":29},"2025-12-30","ACTUAL",{"date":31,"type":29},"2025-02-01",{"date":33,"type":20},"2031-12",{"name":35,"class":36},"Probelte Pharma S.L.U.","INDUSTRY",13,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100469659","phase-3-efficacy-and-safety-assessment-of-beltavac-with-polymerized-extract-of-hdm-100469659","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.","12 Years","65 Years",{"count":49,"type":20},350,"INTERVENTIONAL",[52],"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",[55],"House Dust Mite Allergy","2024-07-17",{"date":58,"type":29},"2024-07-18",{"date":60,"type":29},"2022-01-17",{"date":62,"type":20},"2026-06",{"name":35,"class":36},18,""]