Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT05470894
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2022-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Injury After COVID-19 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with liver injury after COVID-19 vaccination', 'timeFrame': 'Within 24 weeks after COVID-19 vaccination', 'description': 'The COVID-19 vaccine-related liver injury (such as elevated liver enzymes, total bilirubin, etc.) was recorded and its spectrum and profile were evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subjects After COVID-19 Vaccination']}, 'descriptionModule': {'briefSummary': 'The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is still raging across the world and vaccination is expected to lead us out of this pandemic. Although the efficacy of these vaccines is beyond doubt, safety still remains a concern. Liver injury, such as autoimmune hepatitis (AIH), has been reported after COVID-19 vaccination. The aim of this prospective study is to investigate the spectrum and profile of liver injury after COVID-19 vaccination in Asia-Pacific region and to explore the potential risk factors for the development of liver injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects after COVID-19 vaccination', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have received at least one dose of approved COVID-19 vaccine;\n* Volunteer to participate in this study.\n\nExclusion Criteria:\n\n* No valid consent.'}, 'identificationModule': {'nctId': 'NCT05470894', 'briefTitle': 'Liver Injury After COVID-19 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Humanity & Health Medical Group Limited'}, 'officialTitle': 'APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)', 'orgStudyIdInfo': {'id': 'APCOVLI-2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 Vaccination Group', 'description': 'Subjects who have received at lease one dose of approved COVID-19 vaccine', 'interventionNames': ['Biological: Approved COVID-19 vaccine']}], 'interventions': [{'name': 'Approved COVID-19 vaccine', 'type': 'BIOLOGICAL', 'description': 'Vaccination for COVI9-19', 'armGroupLabels': ['COVID-19 Vaccination Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Humanity & Health Medical Group Limited', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nihon University School of Medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'George Lau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanity & Health Medical Group'}, {'name': 'Masao Omata, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tokyo University'}, {'name': 'Tatsuo Kanda, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nihon University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanity & Health Medical Group Limited', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tokyo University', 'class': 'OTHER'}, {'name': 'Nihon University School of Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}