Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT02065856
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2014-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2014-02-17', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of patients with adverse reactions', 'timeFrame': 'Participants will be followed for an expected average of 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Frequency of patients with systemic reactions according to EAACI classification', 'timeFrame': 'Participants will be followed for an expected average of 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen']}, 'descriptionModule': {'briefSummary': 'This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks.\n\nSafety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.\n* Positive Skin Prick Test to Salsola kali pollen (wheal diameter ≥ 3 mm).\n* Documenting in the last 5 years a positive specific Immunoglobulin E against Salsola kali pollen (≥ Class 2; ≥0.70 KU/L).\n\nExclusion Criteria:\n\n* Forced expiratory volume at one second 1 \\< 70% of predicted value at screening after adequate pharmacologic treatment.\n* Uncontrolled or severe asthma.\n* History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.\n* At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).\n* Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).\n* Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.\n* Immunotherapy with Cupressus arizonica or Salsola kali pollen extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted) or concomitant immunotherapy with any other allergen.\n* History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.\n* History of severe and recurrent angioedema.'}, 'identificationModule': {'nctId': 'NCT02065856', 'acronym': 'AV-X-02', 'briefTitle': 'An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy', 'orgStudyIdInfo': {'id': '2013-001728-20'}, 'secondaryIdInfos': [{'id': '2013-001728-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVANZ Salsola kali', 'description': 'Subcutaneous immunotherapy', 'interventionNames': ['Biological: AVANZ Salsola']}], 'interventions': [{'name': 'AVANZ Salsola', 'type': 'BIOLOGICAL', 'description': 'AVANZ Salsola', 'armGroupLabels': ['AVANZ Salsola kali']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'overallOfficials': [{'name': 'PURIFICACION GONZÁLEZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario de Alicante'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}