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Higher dose of hepatitis b drug put to the test in damaged livers

NCT ID NCT07816094

Disease control Sponsor: Bangladesh Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Researchers are testing whether a higher daily dose of the antiviral drug entecavir suppresses hepatitis B virus better than the standard lower dose in adults whose livers are already scarred and failing. The trial enrolls 48 people with hepatitis B and decompensated cirrhosis. Participants take either 0.5 mg or 1.0 mg of entecavir once a day for 24 weeks, and researchers measure how much the virus levels drop, along with liver function and safety.

What this could mean

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

Active substance
entecavir, an antiviral drug taken by mouth
What this could lead to
If one dose works better, doctors could have clearer guidance on how to suppress hepatitis B in people whose livers are already badly damaged.
What could go wrong
This is a small, short trial of 48 people. It may not show a clear difference between the doses, and it cannot prove that suppressing the virus reverses cirrhosis or prevents liver cancer.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

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.

Ages

18 years and older

Sex

Male participants only

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 years or older. 2. HBV-related decompensated cirrhosis of liver based on clinical, biochemical and radiological evidence. 3. Detectable level of HBV DNA irrespective of HBeAg status. Exclusion Criteria: 1. Clinical, biochemical, or radiological evidence of hepatocellular carcinoma. 2. Coinfection with HCV. 3. Patient is ongoing antiviral treatment. 4. Cirrhosis due to other causes. 5. Acute-on-chronic liver failure, defined according to the criteria established by APASL. 6. Pregnancy. 7. Patients with known hypersensitivity or allergy to Entecavir.

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection

As listed by the trial registrant

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

Hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bangladesh Medical university

    RECRUITING

    Dhaka, Dhaka Division, 1000, Bangladesh

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