Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-02 @ 6:28 PM
Study NCT ID:
NCT00833066
Status:
COMPLETED
Last Update Posted:
2011-11-17
First Post:
2009-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis
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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-16', 'studyFirstSubmitDate': '2009-01-29', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of allergic reaction', 'timeFrame': 'within the first 14 days (plus or minus 1 day)'}], 'secondaryOutcomes': [{'measure': 'Immunological assessment', 'timeFrame': '9 months'}, {'measure': 'Allergy symptom and medication scores', 'timeFrame': 'grass pollen season 2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hay fever', 'grass pollen allergy'], 'conditions': ['Seasonal Allergic Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has given written informed consent\n* Age between 18 and 50 years\n* The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status\n* Male or non pregnant, non-lactating female\n* Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))\n* Allergy:\n\nA history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years A positive skin prick test (wheal diameter \\>= 3 mm) to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE \\> 0.7 kU/l) Asymptomatic to perennial inhalant allergens.\n\nExclusion Criteria:\n\n* Subjects with current or past immunotherapy (any time in the past)\n* Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)\n* Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)\n* Subjects with a history of hepatic or renal disease\n* Subjects symptomatic to perennial inhalant allergens\n* Subject with malignant disease, autoimmune disease\n* Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)\n* Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…)\n* Subjects requiring beta-blockers medication\n* Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)\n* Subject with febrile illness (\\> 37.5°C, oral)\n* A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies\n* The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry\n* Receipt of blood or a blood derivative in the past 6 months preceding trial entry\n* Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial\n* Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial\n* Use of long-acting antihistamines\n* Any condition which could be incompatible with protocol understanding and compliance\n* Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship\n* Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol\n* Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start\n* A history of hypersensitivity to the excipients\n* Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)\n* Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator\n* Subjects who participated to trial BTT-gpASIT002"}, 'identificationModule': {'nctId': 'NCT00833066', 'briefTitle': 'Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioTech Tools S.A.'}, 'officialTitle': 'Preliminary Assessment of the Clinical Tolerability, Safety and Immunogenicity of Three Different Doses of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'BTT-gpASIT003'}, 'secondaryIdInfos': [{'id': 'EudraCT 2008-006369-10'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'gpASIT 25', 'interventionNames': ['Biological: gpASIT+TM']}, {'type': 'EXPERIMENTAL', 'label': 'gpASIT 100', 'interventionNames': ['Biological: gpASIT+TM']}, {'type': 'EXPERIMENTAL', 'label': 'gpASIT 400', 'interventionNames': ['Biological: gpASIT+TM']}], 'interventions': [{'name': 'gpASIT+TM', 'type': 'BIOLOGICAL', 'description': 'entero-coated capsules containing 25µg of gpASIT+TM', 'armGroupLabels': ['gpASIT 25']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'placebo entero-coated capsules', 'armGroupLabels': ['Placebo']}, {'name': 'gpASIT+TM', 'type': 'BIOLOGICAL', 'description': 'entero-coated capsules containing 100µg of gpASIT+TM', 'armGroupLabels': ['gpASIT 100']}, {'name': 'gpASIT+TM', 'type': 'BIOLOGICAL', 'description': 'entero-coated capsules containing 400µg of gpASIT+TM', 'armGroupLabels': ['gpASIT 400']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'University Hospital Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'University Hospital Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioTech Tools S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}