ClinicalTrials.gg
Not yet recruitingNCT06653140Updated Oct 28, 2024

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

An observational study in Hepatitis of Unknown Aetiology, sponsored by Minghui Li. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Minghui Li · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Hepatitis of Unknown Aetiology

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Keywords

  • Unexplained hepatitis
03

In context

Hepatitis

343 studies on the registry are indexed under Hepatitis; 51 are open to participants now.

This study's planned enrollment of 100 is below the median of 358 across 90 observational studies indexed under Hepatitis.

Browse Hepatitis studies →

Lead sponsor

Minghui Li is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a clear etiology and diagnosis of hepatitis;
  2. Patients who refuse to cooperate with sampling and sign the form;
  3. Those deemed unsuitable for participation in this study by the researchers.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Forms of outcomes

    Validation of the Diagnostic Performance of the Monitoring Network and Early Warning System for Unexplained and Newly Emerging Acute Hepatitis

    Time frame: three years

Other outcomes

  1. Forms of outcomes

    Research Report on the Types, Genotypes, Gene Mutations, and Evolutionary Molecular Characteristics of Pathogens Causing Newly Emerging Acute Hepatitis

    Time frame: three years

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Study locations

1 site
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References and documents

Publications

  • Sergi CM. Acute Hepatitis of Unknown Origin (AHUO)-The Puzzle Ahead. Diagnostics (Basel). 2022 May 12;12(5):1215. doi: 10.3390/diagnostics12051215. PubMed 35626370 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06653140
Lead sponsor
Minghui Li
Responsible party
Minghui Li (Professor, Beijing Municipal Administration of Hospitals) — Sponsor-investigator
First posted
Oct 22, 2024
Start date
Dec 2024 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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