Liver Injury After COVID-19 Vaccination

NCT ID: NCT05470894

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

379 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-05

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Subjects After COVID-19 Vaccination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 Vaccination Group

Subjects who have received at lease one dose of approved COVID-19 vaccine

Approved COVID-19 vaccine

Intervention Type BIOLOGICAL

Vaccination for COVI9-19

Interventions

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Approved COVID-19 vaccine

Vaccination for COVI9-19

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokyo University

OTHER

Sponsor Role collaborator

Nihon University School of Medicine

UNKNOWN

Sponsor Role collaborator

Humanity & Health Medical Group Limited

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Humanity & Health Medical Group

Masao Omata, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokyo University

Tatsuo Kanda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nihon University School of Medicine

Locations

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Humanity & Health Medical Group Limited

Hong Kong, , Hong Kong

Site Status

Nihon University School of Medicine

Tokyo, , Japan

Site Status

Tokyo University

Tokyo, , Japan

Site Status

Countries

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Hong Kong Japan

Other Identifiers

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APCOVLI-2022-01

Identifier Type: -

Identifier Source: org_study_id

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