HBV Related Acute-on-chronic Liver FailureNCT06865859
Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients
An observational study of HBV Related Acute-on-chronic Liver Failure, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study aimed to profile the peripheral blood immune cells of patients with HBV related acute-on-chronic liver failure using single-cell RNA sequencing to reveal the immunopathological mechanisms of HBV related acute-on-chronic liver failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV Related Acute-on-chronic Liver Failure
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is patients with chronic hepatitis B，HBV related liver cirrhosis，HBV related acute-on-chronic hepatic dysfunction and HBV related acute-on-chronic liver failure
Who may be able to join
- Acute liver failure is a well-defned medical emergency which is defned as a severe liver injury, leading to coagulation abnormality usually with an INR ≥ 1.5, and any degree of mental alteration (encephalopathy) in a patient without pre-existing liver disease and with an illness of up to 4 weeks duration
Who cannot join
- Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yu-Chen Fan, 0086+053182169593, fanyuchen@sdu.edu.cn
About this study
Official title: Single-cell Landscape of Immunological Responses in Patients with Hepatitis B Virus-related Acute-on-chronic Liver Failure
This study aimed to profile the peripheral blood immune cells of patients with HBV related acute-on-chronic liver failure using single-cell RNA sequencing to reveal the immunopathological mechanisms of HBV related acute-on-chronic liver failure.
Read the detailed description
Acute-on-chronic liver failure (ACLF) is a complex clinical syndrome characterized by acute deterioration of liver function in patients with chronic liver disease, exhibiting liver and extrahepatic organ failure and a high short-term mortality. Immune imbalance plays an important role in the progression of HBV-related ACLF. Further investigation of the immune cell characteristics of HBV-related ACLF is helpful to understand its pathogenesis, and may provide reference for the effective therapeutic agent. Single-cell RNA sequencing (scRNA-seq) is the quantitative analysis of transcription at the single-cell level, which could provide systematic analyses of transcriptomic profiles, infer cell-cell interactions. This study will combine single cell transcriptomics and molecular biological experiment to elucidate the immunopathological cell states associated with HBV-related chronic liver disease vs. ACLF.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hepatitis B | Not described | |
| HBV related liver cirrhosis | Not described | |
| HBV related acute-on-chronic hepatic dysfunction | Not described | |
| HBV related acute-on-chronic liver failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV Related Acute-on-chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865859
- Sponsor's protocol ID
- KYLL-202310-036
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-cell Landscape of Immunological Responses in Patients with Hepatitis B Virus-related Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT06865859
- Acronym / sponsor ID
- KYLL-202310-036
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 10 Mar 2025 (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 study aimed to profile the peripheral blood immune cells of patients with HBV related acute-on-chronic liver failure using single-cell RNA sequencing to reveal the immunopathological mechanisms of HBV related acute-on-chronic liver failure.
Detailed description
Acute-on-chronic liver failure (ACLF) is a complex clinical syndrome characterized by acute deterioration of liver function in patients with chronic liver disease, exhibiting liver and extrahepatic organ failure and a high short-term mortality. Immune imbalance plays an important role in the progression of HBV-related ACLF. Further investigation of the immune cell characteristics of HBV-related ACLF is helpful to understand its pathogenesis, and may provide reference for the effective therapeutic agent. Single-cell RNA sequencing (scRNA-seq) is the quantitative analysis of transcription at the single-cell level, which could provide systematic analyses of transcriptomic profiles, infer cell-cell interactions. This study will combine single cell transcriptomics and molecular biological experiment to elucidate the immunopathological cell states associated with HBV-related chronic liver disease vs. ACLF.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic Hepatitis B | – | – |
| HBV related liver cirrhosis | – | – |
| HBV related acute-on-chronic hepatic dysfunction | – | – |
| HBV related acute-on-chronic liver failure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with chronic hepatitis B，HBV related liver cirrhosis，HBV related acute-on-chronic hepatic dysfunction and HBV related acute-on-chronic liver failure
Key inclusion criteria (1 listed)
- Acute liver failure is a well-defned medical emergency which is defned as a severe liver injury, leading to coagulation abnormality usually with an INR ≥ 1.5, and any degree of mental alteration (encephalopathy) in a patient without pre-existing liver disease and with an illness of up to 4 weeks duration
Key exclusion criteria (1 listed)
- Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.
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
Mortality
Time frame: 28 days, 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 HBV Related Acute-on-chronic Liver Failure, run by Qilu Hospital of Shandong University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Fan (0086+053182169593, fanyuchen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.