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OpenTrials
Completed

NCT Number: NCT05470894

Liver Injury After COVID-19 Vaccination

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.

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Key information

Conditions

Subjects After COVID-19 Vaccination

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanity & Health Medical Group Limited, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Approved COVID-19 vaccine

Biological

Vaccination for COVI9-19

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Humanity & Health Medical Group Limited

Other

Collaborators

  • Nihon University School of Medicine
  • Tokyo University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.