Liver Injury After COVID-19 Vaccination

March 21, 2025 updated by: Humanity & Health Medical Group Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

379

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Humanity & Health Medical Group Limited
  • Japan
      • Tokyo, Japan
        • Nihon University School of Medicine
      • Tokyo, Japan
        • Tokyo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects after COVID-19 vaccination

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 Vaccination Group
Subjects who have received at lease one dose of approved COVID-19 vaccine
Biological: Approved COVID-19 vaccine
Vaccination for COVI9-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with liver injury after COVID-19 vaccination
Time Frame: 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.
Within 24 weeks after COVID-19 vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanity & Health Medical Group Limited

Collaborators

Tokyo University
Nihon University School of Medicine

Investigators

  • Principal Investigator: George Lau, MD, Humanity & Health Medical Group
  • Principal Investigator: Masao Omata, MD, PhD, Tokyo University
  • Principal Investigator: Tatsuo Kanda, MD, PhD, Nihon University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

July 21, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APCOVLI-2022-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subjects After COVID-19 Vaccination

Clinical Trials on Approved COVID-19 vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe