Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT00889460
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2009-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of rBet v1 SLIT Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-28', 'studyFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local tolerability', 'timeFrame': 'Assessed every day over 2 weeks'}, {'measure': 'Global safety', 'timeFrame': 'Assessed every day over 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Immunological markers (IgE and IgG4)', 'timeFrame': 'Between selection and follow-up visit (up to 18 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rBet v 1', 'Birch pollen allergy', 'Sublingual Immunotherapy'], 'conditions': ['Birch Pollen-Related Rhinoconjunctivitis', 'Rhinitis, Allergic, Seasonal']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written consent\n* Male or female subject from 18 to 60 years old and in general good health\n* For woman of child bearing potential:\n* Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.\n* Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) \\>0.70 kU/L at screening.\n* FEV1 at least of 80% of predicted values at screening.\n* Subject accepting to comply fully with the protocol.\n\nExclusion Criteria:\n\n* Past or current disease which as judged by the Investigator, may affect the outcome of this study.\n* History of life-threatening asthma,\n* Asthma requiring daily treatment (whatever the pharmaceutical class).\n* Pregnant or lactating woman.\n* Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.\n* Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.\n* Symptoms during the treatment phase due to a sensitivity to a second allergen.\n* Subjects treated with ongoing immunotherapy with another allergen'}, 'identificationModule': {'nctId': 'NCT00889460', 'briefTitle': 'Safety and Tolerability Study of rBet v1 SLIT Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stallergenes Greer'}, 'officialTitle': 'Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen', 'orgStudyIdInfo': {'id': 'VO58.07 DK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo group', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'rBet v 1 tablets', 'interventionNames': ['Biological: rBet v 1']}], 'interventions': [{'name': 'rBet v 1', 'type': 'BIOLOGICAL', 'otherNames': ['rBet v 1.0101'], 'description': 'Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'National University Hospital - Allergy Unit 4222', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Hans-Jorgen MALLING, Pr. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital - Copenhagen - DENMARK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stallergenes Greer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Bruno ROBIN', 'oldOrganization': 'Stallergenes S.A.'}}}}