Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 6:10 PM
Study NCT ID:
NCT00800332
Status:
COMPLETED
Last Update Posted:
2010-11-15
First Post:
2008-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy
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': 'C559986', 'term': 'CYT003-QbG10'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-11', 'studyFirstSubmitDate': '2008-12-01', 'studyFirstSubmitQcDate': '2008-12-01', 'lastUpdatePostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rhinoconjunctivitis symptom and medication scores', 'timeFrame': 'Pre- / Post-Treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhinoconjunctivitis due to house dust mite allergy'], 'conditions': ['Rhinoconjunctivitis', 'Allergies']}, 'referencesModule': {'references': [{'pmid': '21672053', 'type': 'DERIVED', 'citation': 'Klimek L, Willers J, Hammann-Haenni A, Pfaar O, Stocker H, Mueller P, Renner WA, Bachmann MF. Assessment of clinical efficacy of CYT003-QbG10 in patients with allergic rhinoconjunctivitis: a phase IIb study. Clin Exp Allergy. 2011 Sep;41(9):1305-12. doi: 10.1111/j.1365-2222.2011.03783.x. Epub 2011 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens\n* Further criteria as defined in the study protocol\n\nExclusion Criteria:\n\n* Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments\n* Clinically relevant perennial allergy/-ies other than house dust mites allergy\n* Contraindication to any study test or procedure\n* Further criteria as defined in the study protocol"}, 'identificationModule': {'nctId': 'NCT00800332', 'briefTitle': 'Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytos Biotechnology AG'}, 'officialTitle': 'Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy', 'orgStudyIdInfo': {'id': 'CYT003-QbG10 09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: CYT003-QbG10']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: CYT003-QbG10']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CYT003-QbG10', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paide, Tartu, Tallin, Rakvere', 'country': 'Estonia', 'facility': 'Cytos Investigator Sites'}, {'city': 'Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach', 'country': 'Germany', 'facility': 'Cytos Investigator Sites'}, {'city': 'Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen', 'country': 'Germany', 'facility': 'Cytos Investigator Sites'}, {'city': 'N. Faliro, Hiraklion, Athens', 'country': 'Greece', 'facility': 'Cytos Investigator Sites', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Riga, Rezekne', 'country': 'Latvia', 'facility': 'Cytos Investigator Sites'}, {'city': 'Vilnius, Kaunas, Klaipeda', 'country': 'Lithuania', 'facility': 'Cytos Investigator Sites'}, {'city': 'Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti', 'country': 'Romania', 'facility': 'Cytos Investigator Sites'}, {'city': 'Targu Mures, Bukarest, Craiova, Iasi', 'country': 'Romania', 'facility': 'Cytos Investigator Sites'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytos Biotechnology AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Development', 'oldOrganization': 'Cytos Biotechnology'}}}}