APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)
| Registry | NCT05470894 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 379 (Actual) |
| Sponsor | Humanity & Health Medical Group Limited (Other); collaborators: Tokyo University, Nihon University School of Medicine |
| Conditions | Subjects After COVID-19 Vaccination |
| Interventions | Approved COVID-19 vaccine (Biological) |
| Dates | start 2022-09-05, primary completion 2024-12-31, completion 2024-12-31, first posted 2022-07-22, last updated 2025-03-24 |
| Locations | 3 sites in Hong Kong, Japan |
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All trials for Subjects After COVID-19 Vaccination All trials of Approved COVID-19 vaccine
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| COVID-19 Vaccination Group | Biological: Approved COVID-19 vaccine | Subjects who have received at lease one dose of approved COVID-19 vaccine |
Sex: All, ages: 5 Years to any, accepts healthy volunteers
Inclusion Criteria: * Subjects who have received at least one dose of approved COVID-19 vaccine; * Volunteer to participate in this study. Exclusion Criteria: * No valid consent.
| Facility | City | Country | Status |
|---|---|---|---|
| Humanity & Health Medical Group Limited | Hong Kong | Hong Kong | |
| Nihon University School of Medicine | Tokyo | Japan | |
| Tokyo University | Tokyo | Japan |