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Diabetes drug may shield hepatitis b patients from liver failure

NCT ID NCT06364930

Disease control Sponsor: Chinese University of Hong Kong 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This 5-year study tests whether dapagliflozin, a diabetes drug, can prevent serious liver complications in people with chronic hepatitis B and diabetes who already have early liver scarring. 412 participants will receive either dapagliflozin or a placebo daily. The goal is to see if the drug reduces the risk of liver cancer, fluid buildup, bleeding, or other liver-related events.

What this could mean

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

Active substance
Dapagliflozin
What this could lead to
If it works, this could show that dapagliflozin reduces the risk of serious liver problems like liver cancer or fluid buildup in people with hepatitis B and diabetes.
What could go wrong
This is a Phase 4 trial, so dapagliflozin is already approved for diabetes, but its benefit for liver complications is unproven. The 5-year study may not show a clear effect, and side effects are possible.

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 412 people

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

Started

Mar 2024

Expected to finish

Mar 2031

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

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. Patients with chronic hepatitis B on ETV, TDF or TAF monotherapy for at least 12 months. 2. Known or newly diagnosed type 2 diabetes mellitus (T2D), defined as HbA1c ≥5.7% or fasting blood sugar ≥5.6 mmol/L, or random blood sugar ≥11.1 mmol/L, or 2 hours sugar after oral glucose tolerance test ≥7.8 mmol/L. 3. Stable use of anti-diabetic drugs in the last three months. 4. Presence of compensated advanced chronic liver disease (cACLD) with liver stiffness measurement \>10.0 kPa, or significant portal hypertension (spleen stiffness measurement \> 41.3 kPa), or presence any sign of portal hypertension (e.g. splenomegaly, ascites, varices) 5. Aged 18 years old or above. 6. Written informed consent obtained. Exclusion Criteria: 1. Patients with hepatitis C virus (HCV) infection as indicated by a positive antibody to HCV (anti-HCV) serology test. 2. Patients with history of cirrhotic complications or hepatocellular carcinoma 3. Patients with organ transplantation 4. Patients receiving a SGLT2i 5. Contraindications to SGLT2i due to renal insufficiency (GFR \< 45 mL/min/1.73m2) 6. Poor glycaemic control with HbA1c \>9.0% 7. Use of multiple anti-diabetic drugs (3 or more) 8. Change in anti-diabetic drugs in the last three months. 9. Serious medical illnesses or malignancy 10. Age \< 18 years 11. No patient consents

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection type 2 diabetes mellitus

As listed by the trial registrant

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

Chronic 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

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong

More trials for these conditions

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