ClinicalTrials.gg
RecruitingNCT06865859Updated Mar 10, 2025

Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients

An observational study in HBV Related Acute-on-chronic Liver Failure, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Qilu Hospital of Shandong University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 3 years later.

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Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
21
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 48 studies in Acute-On-Chronic Liver Failure with a site in China — 18 open to participants now, 22 under way, none of them phase 3. Acute-On-Chronic Liver Failure · China.

Planned enrollment
23rd of 23
21 · median 411
Started
2023
with 11 others
Observational
23 of 48
9 open now
Primary completion
2025-05
later than 9 of 21 live
Registered
41st of 48
by date
Lead sponsor
2 of 48
Qilu Hospital of Shandong University

Among the 48 studies in Acute-On-Chronic Liver Failure with a site in China, this one is the 23rd largest by planned enrollment of the 23 observational ones that give a count, is one of 12 that started in 2023, is one of 23 observational ones, reaches primary completion later than 9 of the 21 other live ones, and was the 41st registered.

Acute-On-Chronic Liver Failure

167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.

Browse Acute-On-Chronic Liver Failure studies →

Open to participants now

18 of the 48 studies in Acute-On-Chronic Liver Failure with a site in China are open now. Recruiting first, the newest first:

12 more — sign in →

All 18 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 32 Acute-On-Chronic Liver Failure studies recruiting now, 11 (34%) set no upper age limit and 15 (47%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • HBV Related Acute-on-chronic Liver Failure
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

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

Acute liver failure is a well-defned medical emergency which is defned as a severe liver injury, leading to coagulation abnormality usually with an ≥ 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

Exclusion criteria

Exclusion Criteria:

  • Associated with other types of hepatitis virus infection or infection, alcoholic liver disease, 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.
Terms in these criteria, in plain language(3)

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.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
21 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Chronic Hepatitis B
  • HBV related liver cirrhosis
  • HBV related acute-on-chronic hepatic dysfunction
  • HBV related acute-on-chronic liver failure
06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 28 days, 90 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for May 2025, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2025
First posted
Mar 10, 2025
StartActual
Nov 1, 2023
Primary completionEst.
May 2025
CompletionEst.
May 2025
Last update
Mar 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06865859
Responsible party
Sponsor
First posted
Mar 10, 2025
Start date
Nov 1, 2023
Primary completion
May 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Mar 10, 2025

Study contacts

Yu-Chen Fan
Contact
fanyuchen@sdu.edu.cn
0086+053182169593

Oversight

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

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