Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT02968394
Status:
UNKNOWN
Last Update Posted:
2016-11-21
First Post:
2016-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2016-11-11', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Changes in basophil sensitivity during omalizumab co-treatment', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy', 'Bee Venom', 'Immunotherapy', 'Omalizumab']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.', 'detailedDescription': 'Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,\n* honey-bee venom immunotherapy treatment failure due to systemic reactions.\n\nExclusion Criteria:\n\n* systemic mastocytosis,\n* pregnancy,\n* use of beta-adrenergic blocking agents.'}, 'identificationModule': {'nctId': 'NCT02968394', 'briefTitle': 'Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions', 'organization': {'class': 'OTHER', 'fullName': 'The University Clinic of Pulmonary and Allergic Diseases Golnik'}, 'officialTitle': 'Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions', 'orgStudyIdInfo': {'id': 'NEVIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NEVIT', 'description': 'Co treatment with omalizumab during another attempt of immunotherapy introduction', 'interventionNames': ['Drug: omalizumab']}], 'interventions': [{'name': 'omalizumab', 'type': 'DRUG', 'armGroupLabels': ['NEVIT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4204', 'city': 'Golnik', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Peter Kopac, MD', 'role': 'CONTACT', 'email': 'peter.kopac@klinika-golnik.si', 'phone': '+386 4 25 69 100'}], 'facility': 'University Clinic of Pulmonary and Allergic Diseases Golnik', 'geoPoint': {'lat': 46.33333, 'lon': 14.33333}}], 'centralContacts': [{'name': 'Peter Kopac, MD', 'role': 'CONTACT', 'email': 'peter.kopac@klinika-golnik.si', 'phone': '+386 4 25 69 100'}], 'overallOfficials': [{'name': 'Mitja Košnik, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Clinic of Pulmonary and Allergic Diseases Golnik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University Clinic of Pulmonary and Allergic Diseases Golnik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}