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Should older hepatitis b patients with normal ALT get antivirals? new study explores

NCT ID NCT07637214

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 250 chronic hepatitis B patients over age 30 who had detectable virus but normal liver enzyme levels (ALT). All had never received antiviral treatment before. Researchers measured how many became virus-negative after 48 weeks of antiviral therapy, and how many normalized their ALT levels. The goal is to understand whether treating this group is beneficial.

What this could mean

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

Active substance
antiviral therapy (nucleoside analogues or interferon-α)
What this could lead to
If successful, this could help doctors decide whether to treat chronic hepatitis B patients who have normal liver enzyme levels, potentially preventing future liver damage.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. The sample size is moderate, and findings may not apply to all patients.

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

250 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2025

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 never received antiviral treatment and come to Tongji hospital for consultation and reexamination.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. CHB patients over 30 years old ； 2. HBV DNA \>20IU/ml and ALT level ≤40U/L； 3. All of them have never received any antiviral treatment(including NAs and interferon-α）。 Exclusion Criteria: 1. pregnancy status; 2. Patients with compensated/decompensated cirrhosis and liver cancer have been diagnosed by imaging or other indicators; 3. HCV, HIV, EB virus/cytomegalovirus infection, schistosomiasis liver disease, drug-induced liver injury, autoimmune hepatitis and alcoholic liver disease; 4. Use immunosuppressants ; 5. Previous history of liver cancer, organ transplantation and alcoholism (male ≥30 g/d, female ≥20 g/d); 6. Insufficient follow-up time and imperfect clinical/laboratory informations; 7. Combined with other major diseases.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome hepatitis B virus infection

As listed by the trial registrant

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

Chronic Hepatitis B Treatment

Contacts and locations

Locations

  • Tongji Hospital,Wuhan,Hubei

    Wuhan, Hubei, 430000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.