Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT01159951
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2010-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Trends Over Time of Hepatitis Related Incidence in Panama
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No samples retained'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-07-08', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis)', 'timeFrame': 'In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)'}], 'secondaryOutcomes': [{'measure': 'Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year', 'timeFrame': 'From year 2000 until year 2010'}, {'measure': 'Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups', 'timeFrame': 'From year 2000 until year 2010'}, {'measure': 'Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region', 'timeFrame': 'From year 2000 until year 2010'}]}, 'conditionsModule': {'conditions': ['Hepatitis']}, 'referencesModule': {'references': [{'pmid': '25981490', 'type': 'DERIVED', 'citation': 'Estripeaut D, Contreras R, Tinajeros O, Castrejon MM, Shafi F, Ortega-Barria E, DeAntonio R. Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 2015 Jun 22;33(28):3200-7. doi: 10.1016/j.vaccine.2015.04.100. Epub 2015 May 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.', 'detailedDescription': 'In this study, systematic review of the databases of epidemiologic surveillance system (Ministry of Health), for hepatitis related outcomes will be performed. The analysis will be performed by age group, years and country region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population to be studied will be all subjects reported with hepatitis related outcomes to the Epidemiologic Surveillance System of the Ministry of Health of Panama, between 2000 and 2010.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT01159951', 'briefTitle': 'Analysis of Trends Over Time of Hepatitis Related Incidence in Panama', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Time Trend Analysis of the Incidence of Hepatitis- Related Outcomes (Viral Hepatitis A and Unspecified Viral Hepatitis) Reported to the Surveillance System of Panama, 2000-2010', 'orgStudyIdInfo': {'id': '112263'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatitis Cohort', 'description': 'Subjects suffering with hepatitis', 'interventionNames': ['Other: Epidemiologic Surveillance System of the Ministry of Health of Panama']}], 'interventions': [{'name': 'Epidemiologic Surveillance System of the Ministry of Health of Panama', 'type': 'OTHER', 'description': 'Systematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama', 'armGroupLabels': ['Hepatitis Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clayton', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 9.00425, 'lon': -79.57855}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}