Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT03604718
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2018-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of treatment-related local and systemic reactions', 'timeFrame': '1 year', 'description': 'Number of adverse reactions occurred during the treatment period and classified according to the WAO standard'}], 'secondaryOutcomes': [{'measure': 'Rhinoconjuntivitis medication intake', 'timeFrame': '1 year', 'description': 'Medication intake for allergy symptons control at baseline, 6 and 12 months'}, {'measure': 'Visual analogue Scale Score', 'timeFrame': '1 year', 'description': 'Psycometric scale that assesses the global allergic disease discomfort. It is a 10 cm line representing severity from 0:"no symptoms" to 10 "highest level of symptoms"'}, {'measure': 'IgE and IgG4 specific quantification', 'timeFrame': '1 year', 'description': 'IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinoconjunctivitis With or Without Allergic Asthma']}, 'descriptionModule': {'briefSummary': 'Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients', 'detailedDescription': 'This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.\n\nPatients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the age of 5 on, who suffer from allergic rhinoconjunctivitis caused by Alternaria alternata', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis\n* Positive skin testing or IgE determination to the relevant allergen\n\nExclusion Criteria:\n\nPatients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline'}, 'identificationModule': {'nctId': 'NCT03604718', 'briefTitle': 'Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probelte Pharma S.L.U.'}, 'officialTitle': 'Observational Prospective Study to Assess the Safety and Effectiveness Profile of Beltavac® Polymerized With Alternaria Alternata', 'orgStudyIdInfo': {'id': 'PRO-POL-2017-01'}, 'secondaryIdInfos': [{'id': 'PRO-BEL-2017-01', 'type': 'OTHER', 'domain': 'AEMPS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Beltavac® Polymerized with Alternaria alternata', 'type': 'BIOLOGICAL', 'description': 'Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vic', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Universitary Hospital of Vic', 'geoPoint': {'lat': 41.93012, 'lon': 2.25486}}, {'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Medical Center Fedear', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Torrejón de Ardoz', 'state': 'Madrid', 'country': 'Spain', 'facility': 'University Hospital of Torrejon', 'geoPoint': {'lat': 40.45535, 'lon': -3.46973}}, {'city': 'Cartagena', 'state': 'Murcia', 'country': 'Spain', 'facility': 'University Hospital of Cartagena', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'city': 'Talavera de la Reina', 'state': 'Toledo', 'country': 'Spain', 'facility': 'Clínica de Alergia Mar Jiménez Lara', 'geoPoint': {'lat': 39.96348, 'lon': -4.83076}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Allergo Centre', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Medical Center Cenvi Medic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Alergomundo', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Torrelodones', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Ojeda Clinic', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30100', 'city': 'Murcia', 'country': 'Spain', 'facility': 'University Hospital Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Reina Sofia Universitary Hospital', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Toledo', 'country': 'Spain', 'facility': 'Clinica Alergologica Dr Moral', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'overallOfficials': [{'name': 'Inmaculada Buendía Jiménez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Probelte Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probelte Pharma S.L.U.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}