Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT01719133
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2012-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D006632', 'term': 'Histamine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-31', 'studyFirstSubmitDate': '2012-10-26', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'skin prick test reactivity', 'timeFrame': '15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergy', 'birch'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '23725004', 'type': 'DERIVED', 'citation': 'Pellaton C, Perrin Y, Boudousquie C, Barbier N, Wassenberg J, Corradin G, Thierry AC, Audran R, Reymond C, Spertini F. Novel birch pollen specific immunotherapy formulation based on contiguous overlapping peptides. Clin Transl Allergy. 2013 Jun 1;3(1):17. doi: 10.1186/2045-7022-3-17.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.', 'detailedDescription': 'The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter \\> 4 mm with erythema)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of allergy symptoms during previous birch pollen season\n* positive skin prick test to birch pollen extract\n\nExclusion Criteria:\n\n* pregnancy\n* uncontrolled asthma\n* other significant clinical conditions or immune disorders\n* subjects taking antihistamines or drugs with antihistamine activity'}, 'identificationModule': {'nctId': 'NCT01719133', 'briefTitle': 'Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anergis'}, 'officialTitle': 'Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1', 'orgStudyIdInfo': {'id': 'AN002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All subjects', 'description': 'placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5', 'interventionNames': ['Drug: placebo', 'Drug: Histamine', 'Drug: AllerT1', 'Drug: AllerT2', 'Drug: AllerT3', 'Drug: AllerT4', 'Drug: AllerT5', 'Drug: mix of AllerT1-T2-T3', 'Drug: mix of AllerT4-T5']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'otherNames': ['saline'], 'description': 'saline solution', 'armGroupLabels': ['All subjects']}, {'name': 'Histamine', 'type': 'DRUG', 'otherNames': ['Histamine solution'], 'description': 'positive control', 'armGroupLabels': ['All subjects']}, {'name': 'AllerT1', 'type': 'DRUG', 'description': 'synthetic peptide T1', 'armGroupLabels': ['All subjects']}, {'name': 'AllerT2', 'type': 'DRUG', 'description': 'synthetic peptide T2', 'armGroupLabels': ['All subjects']}, {'name': 'AllerT3', 'type': 'DRUG', 'description': 'synthetic peptide T3', 'armGroupLabels': ['All subjects']}, {'name': 'AllerT4', 'type': 'DRUG', 'description': 'synthetic peptide T4', 'armGroupLabels': ['All subjects']}, {'name': 'AllerT5', 'type': 'DRUG', 'description': 'synthetic peptide T5', 'armGroupLabels': ['All subjects']}, {'name': 'mix of AllerT1-T2-T3', 'type': 'DRUG', 'otherNames': ['AllerT'], 'description': 'mix of peptides T1, T2 and T3', 'armGroupLabels': ['All subjects']}, {'name': 'mix of AllerT4-T5', 'type': 'DRUG', 'otherNames': ['mix T4-T5'], 'description': 'mix T4-T5', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Francois Spertini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anergis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}