Liver Injury After COVID-19 Vaccination

APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05470894

Enrollment

379

Registered

2022-07-22

Start date

2022-09-05

Completion date

2024-12-31

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects After COVID-19 Vaccination

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.

Interventions

BIOLOGICALApproved COVID-19 vaccine

Vaccination for COVI9-19

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Hong Kong, Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026