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Can viral markers predict who survives hepatitis b liver failure?

NCT ID NCT07815418

Knowledge-focused Sponsor: Tongji Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

This observational study follows people with hepatitis B-related acute-on-chronic liver failure who receive one of three antiviral drugs: entecavir, tenofovir alafenamide, or tenofovir amibufenamide. Researchers measure two newer virological markers, HBV RNA and HBcrAg, over time and track 60-day survival and 24-week HBV DNA negativity. The goal is to see whether these markers relate to prognosis and whether the three drugs differ in safety or outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
entecavir, tenofovir alafenamide, and tenofovir amibufenamide
What this could lead to
If the virological markers track with outcomes, doctors could use them to guide which antiviral drug to choose for people with hepatitis B-related liver failure.
What could go wrong
This is an observational study, so it can show patterns but cannot prove that one drug causes better survival. The results may not apply to patients outside the age and severity range studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

235 people

The number who actually took part.

Started

Feb 2022

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The research population is CHB patients who have a diagnosis of ACLF according to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL)

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-70; 2. Hepatitis B surface antigen positive ≥ 6 months; 3. TBil\>5mg/dl or 85 μ mol/L; INR ≥ 1.5 or PTA \< 40%; Clinical manifestation of ascites and/or hepatic encephalopathy within four weeks of onset (According to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL)) Exclusion Criteria: 1. Patients with malignant liver tumors and other tumors; 2. Pregnant or lactating women; 3. Patients with liver diseases caused by combined hepatitis C virus infection, hepatitis E virus infection, autoimmune hepatitis, poisoning, drug-induced liver damage, acute variceal bleeding, alcoholic liver disease, and genetic metabolic liver disease; 4. Patients with human immunodeficiency virus infection or other immunodeficiency diseases; 5. Patients with other organ dysfunction or failure; 6. Combined using more than one NAs drug

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute on chronic liver failure (ACLF) Hepatitisb Treatment

Contacts and locations

Locations

  • Tongji Hospital

    Wuhan, Hubei, 430000, China

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