Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT02324218
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This Study Aims to Determine the Incidence, of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161429}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2014-12-11', 'studyFirstSubmitQcDate': '2014-12-18', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of new HepB diagnosis among patients between 0-80 years of age previously diagnosed with DM, between 2000 and 2012, in the UK CPRD or Hospital Episodes Statistics (HES).', 'timeFrame': 'Up to 12 years'}, {'measure': 'Occurrence of new HepB diagnosis among non-DM patients between 0-80 years of age, in the UK CPRD or HES.', 'timeFrame': 'Up to 12 years'}], 'secondaryOutcomes': [{'measure': 'Hospitalisation episode recorded in HES due to HepB infection or complications among patients between 0-80 years of age previously diagnosed with DM and in DM-free (non-DM) patients, in the UK, for whom CPRD-HES linkage is available.', 'timeFrame': 'Up to 12 years'}, {'measure': 'All cause mortality among HepB cases in the DM and DM-free (non-DM) patients between 0-80 years of age, in the UK.', 'timeFrame': 'Up to 12 years'}, {'measure': 'HepB cause-specific mortality among DM and DM-free (non-DM) patients between 0-80 years of age, in the UK for whom CPRD-ONS mortality linkage is available.', 'timeFrame': 'Up to 12 years'}, {'measure': 'New-onset or prevalent HepB diagnosis among new-onset or prevalent DM and DM-free (non-DM) patients between 0-80 years of age, in the UK, regardless of the onset of HepB in relation to the diagnosis of DM.', 'timeFrame': 'Up to 12 years'}]}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Hepatitis B', 'Incidence'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '29220868', 'type': 'DERIVED', 'citation': 'Ferreira GLC, Marano C, De Moerlooze L, Guignard A, Feng Y, El Hahi Y, van Staa T. Incidence and prevalence of hepatitis B in patients with diabetes mellitus in the UK: A population-based cohort study using the UK Clinical Practice Research Datalink. J Viral Hepat. 2018 May;25(5):571-580. doi: 10.1111/jvh.12841. Epub 2018 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large population-based cohort in United Kingdom (UK) using data from the CPRD database.', 'detailedDescription': 'The study is a retrospective, observational, descriptive, cohort study, in DM and non-DM patients of 0-80 years of age. As a first step the eligible baseline population from CPRD will be defined as per the data quality qualifiers, which include subjects aged 0-80 years, "acceptable for research" registered in practices classified as "up to standard" by the CPRD for the time period 2000- 2012. The following cohorts will be defined from the baseline population:\n\n* DM cohort: Patients diagnosed with type 1 or type 2 DM, as confirmed by diagnosis medical codes with or without a DM related drug or monitoring devices prescription.\n* Non-DM cohort: Patients with the absence of personal history of DM diagnosis or antidiabetic drug or monitoring devices prescriptions.\n\nFrom the above defined cohorts, HepB cases will be identified based on clinical diagnosis codes, Hospital Episodes Statistics (HES) or positive diagnostic laboratory tests results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the subjects with diabetes mellitus diagnosed with hepatitis B, reported in the CPRD database of UK, from the Year 2000 to 2012.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects, 0 to 80 years of age during the study period.\n* Subjects acceptable for research as per CPRD definition:\n\n * Acceptable flag for research.\n* Subjects with at least 12 months of observation time at the time of inclusion in the study:\n\n * Subjects have to be registered in the CPRD database for at least 12 months at the date of inclusion in the study.\n * Subjects have to be registered in a general practitioner practice classified as 'up to standard' for at least 12 months at the date of inclusion in the study.\n* Particular Case of New Born Children.\n\n * To ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in CPRD.\n* Inclusion Date\n\n * Inclusion criteria will be assessed for each calendar year between the Years 2000 and 2012.\n\nExclusion Criteria:\n\n• For the analyses requiring the inclusion of HES data, HES records linked with more than one CPRD patient will be excluded from the analyses."}, 'identificationModule': {'nctId': 'NCT02324218', 'briefTitle': 'This Study Aims to Determine the Incidence, of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Incidence of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age, in the United Kingdom Clinical Practice Research Datalink (CPRD)', 'orgStudyIdInfo': {'id': '201335'}, 'secondaryIdInfos': [{'id': '14_114', 'type': 'OTHER', 'domain': 'Independent Scientific Advisory Committee (ISAC) ID'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes mellitus Group', 'description': 'All the subjects with diabetes mellitus diagnosed with hepatitis B, reported in the CPRD database of UK, from the Year 2000 to 2012.', 'interventionNames': ['Other: Data collection']}, {'label': 'Non-Diabetes mellitus Group', 'description': 'All the subjects with hepatitis B who are diagnosed negative diabetes mellitus, reported in the CPRD database of UK, from the Year 2000 to 2012.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data extraction from CPRD database of UK.', 'armGroupLabels': ['Diabetes mellitus Group', 'Non-Diabetes mellitus Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}