[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576828":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":35,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":106,"collaborators":23,"id":108,"slug":23,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":23,"enrollmentInfo":117,"targetDuration":23,"studyType":120,"phases":23,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":59,"whyStopped":23,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Inmunotek S.L.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and\u002For Vespula spp.).","Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).","12 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg\u002FmL is reached, in participants suffering spontaneous natural stings during the 1-year follow-up.","Registration of allergic reactions, spontaneous natural stings and a controlled sting test in participants sensitised to hymenoptera venom (Apis mellifera and\u002For Vespula spp.).",{"measure":18,"description":19,"timeFrame":12},"Immunological parameters of the participants after 12 months of treatment.","Immunological study: total IgE, specific IgE, IgG4, IgG1 (total extract and molecular components of Vespula spp. and Apis mellifera). The immunological analysis will be performed according to the usual clinical practice of the site and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.",{"measure":21,"description":22,"timeFrame":12},"SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.","The quality of life questionnaire consists of 14 questions, the first nine questions are mandatory. The score for each question is inverse to the order of the answer, i.e. the first answer scores 7 and the seventh 1. The score shall be obtained by adding up all the questions answered and dividing by the total number of questions answered. .The total score goes from 1 to 7, with 1 indicating the worst quality of life and 7 the best.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.","Participants of both gender aged 14 years or more diagnosed of allergy to Apis mellifera and\u002For Vespula spp. venom, susceptible to receive ITVH according to standard clinical practice.",[30],{"label":31,"type":23,"description":32,"interventionNames":33},"Patients allergic to hymenoptera venom","Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07)",[34],"Biological: VENOX",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":23},"BIOLOGICAL","VENOX","Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.",[31],[42],{"name":43,"affiliation":44,"role":45},"Arantza Vega Castro","University of Guadalajara","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":23,"email":51},"Miguel Casanovas","CONTACT","+34 91208942","mcasanovas@inmunotek.com",{"name":53,"role":49,"phone":54,"phoneExt":23,"email":55},"Raquel Caballero","+34 607600638","rcaballero@inmunotek.com",[57,79,91],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Hospital Universitario Fundación Alcorcón","RECRUITING","Alcorcón","Madrid","28922","Spain","ES",{"type":66,"coordinates":67},"Point",[68,69],-3.82487,40.34582,{"lat":69,"lon":68},[72,76],{"name":73,"role":49,"phone":74,"phoneExt":23,"email":75},"Teresa Alfaya","+34 916219400","teresa.alfaya@salud.madrid.org",{"name":77,"role":78,"phone":23,"phoneExt":23,"email":23},"Jesús Macías Iglesias","SUB_INVESTIGATOR",{"facility":80,"status":59,"city":81,"state":23,"zip":23,"country":63,"countryCode":64,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Hospital Reina Sofía","Córdoba",{"type":66,"coordinates":83},[84,85],-4.77275,37.89155,{"lat":85,"lon":84},[88],{"name":89,"role":49,"phone":23,"phoneExt":23,"email":90},"M.ª Berta Ruiz León, Dr","rulebe@gmail.com",{"facility":92,"status":59,"city":93,"state":23,"zip":94,"country":63,"countryCode":64,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Hospital Universitario de Guadalajara","Guadalajara","19002",{"type":66,"coordinates":96},[97,98],-3.16185,40.62862,{"lat":98,"lon":97},[101,104],{"name":43,"role":49,"phone":102,"phoneExt":23,"email":103},"+34 949209200","arantza.vega@gmail.com",{"name":105,"role":78,"phone":23,"phoneExt":23,"email":23},"Juan María Beitia Mazuecos",{"type":107,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100576828",false,"NCT06790368","Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.","Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.","Venox-23","Inclusion Criteria:\n\n* The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.\n* Participants of both sexes aged 14 years or more.\n* Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.\n* Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.\n* Participants who do not agree to participate and\u002For do not sign the informed consent form.\n* Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.","ALL","14 Years",{"count":118,"type":119},80,"ESTIMATED","OBSERVATIONAL","Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.",[123,124,125],"Allergy, Insect Venom","Allergy Insect Stinging","Insect Sting Allergy",[127,128,129,130,131],"Allergy","Immunotherapy","Apis mellifera","Vespula sp","controlled sting","2025-04-30",{"date":134,"type":135},"2025-05-01","ACTUAL",{"date":137,"type":135},"2025-01-01",{"date":139,"type":119},"2026-06-01",{"name":5,"class":6},3]