Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 10:39 AM
Study NCT ID:
NCT01381432
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001379', 'term': 'Azathioprine'}], 'ancestors': [{'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-09', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events related to azathioprine tablets', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antirejection'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The following subjects to whom azathioprine tablet is administered for "the suppression of lung transplant rejection";\n\n1. Subjects on whom lung transplantation is performed after approval and to whom azathioprine tablet is administered from transplant surgery to May 2010.\n2. Subjects on whom lung transplantation is performed before approval and who have already completed the drug administeration as well as during the drug administration at the time of the contract terminiation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who undergo lung transplantation and azathioprine tablets were administered\n\nExclusion Criteria:\n\n* Subjects with hypersensitivity to the ingredients of azathioprine tablet\n* Subjects who is pregnant or might be pregnant\n* Subjects whose white count is lower than 3000/cubic millimeter'}, 'identificationModule': {'nctId': 'NCT01381432', 'briefTitle': 'Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)', 'orgStudyIdInfo': {'id': '112314'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects prescribed azathioprine tablet', 'description': 'Subjects prescribed azathioprine tablet during study period after the lung transplantation', 'interventionNames': ['Drug: Azathioprine']}], 'interventions': [{'name': 'Azathioprine', 'type': 'DRUG', 'description': 'At the start of treatment, 2 to 3 mg per kg of body weight each day. For the rest of treatment, 1 to 2 mg per kg of body weight each day.', 'armGroupLabels': ['Subjects prescribed azathioprine tablet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}