Research on the Monitoring, Pathogen Screening, and Diagnostic System for Unexplained and Newly Emerging Acute Hepatitis

October 25, 2024 updated by: Minghui Li
This project will collect blood and liver tissue samples of unexplained and newly emerging acute hepatitis through a monitoring system. After excluding infections of hepatitis A-E viruses using enzyme immunoassay, chemical, and photometric methods to detect infection markers, multiplex PCR technology will be employed to screen for related pathogens. The goal is to establish a sensitive, rapid, and accurate diagnostic system.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Unexplained hepatitis refers to cases where patients exhibit acute hepatitis symptoms that are not caused by hepatitis A, B, C, D, or E viruses, also known as non-hepatotropic viral hepatitis. On March 31, 2022, the UK first reported five cases of severe acute hepatitis of unknown origin in children. Subsequently, suspected cases were reported in multiple countries worldwide. As of November 2022, 1,010 cases have been reported in 35 countries, primarily affecting children under five years old, with approximately 5% of cases requiring liver transplantation, indicating a high severity rate. Possible causes of unexplained hepatitis include infections by viruses other than hepatitis viruses and autoimmune reactions. Newly emerging acute hepatitis refers to outbreaks of hepatitis caused by newly discovered pathogens or other factors. Research has indicated that the etiology and pathogenesis of unexplained hepatitis in children are related to infections by human adenovirus, adeno-associated virus 2 (AAV2), and cytomegalovirus. European countries conducted adenovirus testing on 457 children, with a positivity rate of 51.6% (236 cases). Two studies in the UK found high levels of AAV2 in the blood and liver samples of some children through metagenomic sequencing and PCR testing, although the specific pathogenesis remains unclear. Unexplained hepatitis and newly emerging acute hepatitis can cause a significant disease burden. Reports and discoveries in China are relatively rare. To accurately understand the incidence and pathogenic mechanisms of unexplained and newly emerging acute hepatitis in China, it is crucial to conduct monitoring, pathogen screening, and diagnostic system research. This project aims to collect blood and liver tissue samples of unexplained and newly emerging acute hepatitis through a monitoring system. After excluding infections of hepatitis A-E viruses using enzyme immunoassay, chemical, and photometric methods to detect infection markers, multiplex PCR technology and other methods will be employed to establish a pathogen detection platform for unexplained hepatitis. This will involve nucleic acid testing for common non-hepatotropic viruses that cause liver damage and constructing a stable multiplex PCR reaction system to achieve rapid screening and diagnosis of clinical samples. Understanding the incidence and dynamic trends of unexplained and newly emerging acute hepatitis, and studying their etiology and influencing factors through pathogen screening and diagnostic research, will provide technical support for the prevention and control of these conditions.

Study Type

Observational

Enrollment (Estimated)

100

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

  • China
    • 北京市
      • Beijing, 北京市, China, 100015
        • Beijing Ditan Hospital, Capital Medical University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Based on the suspected acute hepatitis case samples collected nationwide and the newly discovered suspected cases of unexplained and newly emerging acute hepatitis from the monitoring systems of the research centers participating in this study from 2024 to 2026.

Description

Inclusion Criteria:

  1. Exhibiting symptoms of acute hepatitis;
  2. Medical history, signs, and auxiliary examinations suggest hepatitis, but the cause is unknown or it is non-hepatotropic viral hepatitis;
  3. Newly discovered pathogen infection or hepatitis caused by factors other than currently known ones;
  4. The subject voluntarily participates in this study and signs the informed consent form.

Exclusion Criteria:

  1. Patients with a clear etiology and diagnosis of hepatitis;
  2. Patients who refuse to cooperate with sampling and sign the informed consent form;
  3. Those deemed unsuitable for participation in this study by the researchers.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forms of outcomes
Time Frame: three years
Validation of the Diagnostic Performance of the Monitoring Network and Early Warning System for Unexplained and Newly Emerging Acute Hepatitis
three years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forms of outcomes
Time Frame: three years
Research Report on the Types, Genotypes, Gene Mutations, and Evolutionary Molecular Characteristics of Pathogens Causing Newly Emerging Acute Hepatitis
three years

Collaborators and Investigators

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

Sponsor

Minghui Li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 20, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023YFC2306901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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.

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