Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00673218
Status:
UNKNOWN
Last Update Posted:
2012-07-06
First Post:
2008-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000069444', 'term': 'Omalizumab'}, {'id': 'C401983', 'term': 'rhuMAb-E25'}], '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': '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-03', 'studyFirstSubmitDate': '2008-03-30', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basophil histamine release', 'timeFrame': 'After 4 weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IL13', 'Cytokines', 'Basophil stimulation'], 'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': 'If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.', 'detailedDescription': 'Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 19 to 50\n* At least 2 year history of ragweed allergic rhinitis\n* Positive skin prick tests to ragweed \\>5 mm wheal diameter\n* IgE \\<700 iU/m\n\nExclusion Criteria:\n\n* Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days.\n* History of immunotherapy in the past 2 years\n* Exposure to Omalizumab in the past 2 years\n* Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens\n* Asthma other than mild intermittent\n* Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding\n* Known sensitivity to study drug Xolair\n* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study\n* Patients with a previous history of cancer\n* Use of any other investigational agent in the last 30 days'}, 'identificationModule': {'nctId': 'NCT00673218', 'briefTitle': 'The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils', 'orgStudyIdInfo': {'id': 'CIGE025AUS22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Saline injection to match active', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks', 'interventionNames': ['Drug: Xolair']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.', 'armGroupLabels': ['1']}, {'name': 'Xolair', 'type': 'DRUG', 'otherNames': ['Omalizumab, rhumab-E25'], 'description': '150 to 375 mg is administered SC every 2 or 4 weeks', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Robert G Townley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}