ClinicalTrials.gg
RecruitingNCT07275554Updated Dec 10, 2025

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

An observational study in HBV Related Acute-on-chronic Liver Failure, HBV-related Liver Cirrhosis and HBV (Hepatitis B Virus), 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 2025-12-10.

Sponsored by Qilu Hospital of Shandong University · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.

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Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 192 studies in Hepatitis B with a site in China — 39 open to participants now, 49 under way, 1 of them phase 3. Hepatitis B · China.

Planned enrollment
46th of 53
100 · median 407
Started
2024
with 7 others
Observational
53 of 192
17 open now
Primary completion
2026-12
later than 20 of 48 live
Registered
180th of 192
by date

Among the 192 studies in Hepatitis B with a site in China, this one is the 46th largest by planned enrollment of the 53 observational ones that give a count, is one of 8 that started in 2024, is one of 53 observational ones, reaches primary completion later than 20 of the 48 other live ones, and was the 180th registered.

Hepatitis B

1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

Browse Hepatitis B studies →

Open to participants now

39 of the 192 studies in Hepatitis B with a site in China are open now. Recruiting first, the newest first:

33 more — sign in →

All 39 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 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.

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

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 192 studies in Hepatitis B with a site in China, or all of them as a file.
02

Study summary

This study aims to investigate the methylomic features of patients with hepatitis B-related acute-on-chronic liver failure and establish and validate a prognostic risk prediction classification model. The findings are of significant importance for guiding clinical practice and improving patient prognosis. Additionally, a methylomics-based classifier model for liver failure will be developed for disease prognosis analysis and clinical assessment, with the potential to enhance the diagnostic efficiency of liver failure.

03

Conditions studied

  • HBV Related Acute-on-chronic Liver Failure
  • HBV-related Liver Cirrhosis
  • HBV (Hepatitis B Virus)

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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 consists of patients with chronic hepatitis B, Hepatitis B-related liver cirrhosis, and Hepatitis B-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

  • Chronic was persistent hepatitis B surface antigen (HBsAg) seropositivity for more than six months.

Hepatitis B-related liver cirrhosis was diagnosed based on histological examination, typical features on ultrasound or radiological imaging, endoscopic findings of portal hypertension, and clinical history.

Hepatitis B-related acute-on-chronic liver failure meets the diagnostic criteria of the 2018 Asia-Pacific guidelines for the diagnosis and treatment of liver failure.Laboratory tests:Jaundice: Serum total ≥ 85 µmol/L and coagulopathy [ (INR) ≥ 1.5 or Prothrombin Activity (PTA) \< 40%].

Exclusion criteria

Exclusion Criteria:

  • co-infection with other hepatitis viruses; history of hepatocellular carcinoma or other ; concomitant liver disease; or insufficient clinical data.
Terms in these criteria, in plain language(5)

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.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chronic hepatitis B
  • Hepatitis B-related liver cirrhosis
  • Hepatitis B-related acute-on-chronic liver failure
06

What researchers measure

Primary outcomes

  1. Analysis of Methylomic Features in Patients with Hepatitis B-Related Acute-on-Chronic Liver Failure

    Time frame: 48months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.

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

Registered
Nov 27, 2025
First posted
Dec 10, 2025
StartActual
Dec 31, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Dec 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 Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07275554
Responsible party
Sponsor
First posted
Dec 10, 2025
Start date
Dec 31, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 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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