Hepatitis of Unknown AetiologyNCT06653140
Research on the Monitoring, Pathogen Screening, and Diagnostic System for Unexplained and Newly Emerging Acute Hepatitis
An observational study of Hepatitis of Unknown Aetiology, run by Minghui Li at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis of Unknown Aetiology
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Exhibiting symptoms of acute hepatitis;
- Medical history, signs, and auxiliary examinations suggest hepatitis, but the cause is unknown or it is non-hepatotropic viral hepatitis;
- Newly discovered pathogen infection or hepatitis caused by factors other than currently known ones;
- The subject voluntarily participates in this study and signs the informed consent form.
Who cannot join
- Patients with a clear etiology and diagnosis of hepatitis;
- Patients who refuse to cooperate with sampling and sign the informed consent form;
- Those deemed unsuitable for participation in this study by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Minghui Li, 86+13693259096, wuhm2000@sina.com
About this study
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.
- Conditions
- Hepatitis of Unknown Aetiology
- Keywords
- Unexplained hepatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Forms of outcomes
Validation of the Diagnostic Performance of the Monitoring Network and Early Warning System for Unexplained and Newly Emerging Acute Hepatitis
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis of Unknown AetiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minghui Li
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Minghui Li, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653140
- Sponsor's protocol ID
- 2023YFC2306901
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Monitoring, Pathogen Screening, and Diagnostic System for Unexplained and Newly Emerging Acute Hepatitis
- ClinicalTrials.gov ID
- NCT06653140
- Acronym / sponsor ID
- 2023YFC2306901
- Conditions
- Hepatitis of Unknown Aetiology
- Keywords
- Unexplained hepatitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minghui LiOther government
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Exhibiting symptoms of acute hepatitis;
- Medical history, signs, and auxiliary examinations suggest hepatitis, but the cause is unknown or it is non-hepatotropic viral hepatitis;
- Newly discovered pathogen infection or hepatitis caused by factors other than currently known ones;
- The subject voluntarily participates in this study and signs the informed consent form.
Key exclusion criteria (3 listed)
- Patients with a clear etiology and diagnosis of hepatitis;
- Patients who refuse to cooperate with sampling and sign the informed consent form;
- Those deemed unsuitable for participation in this study by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 35626370Sergi CM. Acute Hepatitis of Unknown Origin (AHUO)-The Puzzle Ahead. Diagnostics (Basel). 2022 May 12;12(5):1215. doi: 10.3390/diagnostics12051215.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis of Unknown Aetiology, run by Minghui Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forms of outcomes (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06653140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.