Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT01390766
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic 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': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-30', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of incidence of adverse events related to azathioprine tablets and serious adverse events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antirejection'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver 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 liver transplant rejection";\n\n* Subjects on whom liver transplantation is performed and to whom azathioprine tablet is administered within 1 year after transplant surgery from the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) to May 2010.\n* Subjects on whom liver transplantation is performed before the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) and to whom azathioprine tablet is administered within 1 year after transplant surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who undergo liver transplantation and azathioprine tablet was administered\n\nExclusion Criteria:\n\nAs this is PMS study, there are no exclusion criteria but contraindications are as follows.\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': 'NCT01390766', 'briefTitle': 'Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)', 'orgStudyIdInfo': {'id': '112305'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects prescribed azathioprine tablet', 'description': 'Subjects prescribed azathioprine tablet during study period after the liver transplantation', 'interventionNames': ['Drug: Azathioprine']}], 'interventions': [{'name': 'Azathioprine', 'type': 'DRUG', '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'}}}}