Liver Injury After COVID-19 Vaccination
- Conditions
- Subjects After COVID-19 Vaccination
- Interventions
- Biological: Approved COVID-19 vaccine
- Registration Number
- NCT05470894
- Lead Sponsor
- Humanity & Health Medical Group Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
- Subjects who have received at least one dose of approved COVID-19 vaccine;
- Volunteer to participate in this study.
- No valid consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 Vaccination Group Approved COVID-19 vaccine Subjects who have received at lease one dose of approved COVID-19 vaccine
- Primary Outcome Measures
Name Time Method Number of subjects with liver injury after COVID-19 vaccination Within 24 weeks after COVID-19 vaccination The COVID-19 vaccine-related liver injury (such as elevated liver enzymes, total bilirubin, etc.) was recorded and its spectrum and profile were evaluated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Humanity & Health Medical Group Limited
🇭🇰Hong Kong, Hong Kong
Nihon University School of Medicine
🇯🇵Tokyo, Japan
Tokyo University
🇯🇵Tokyo, Japan