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Study of Bepirovirsen for Patients with Chronic Hepatitis B on Nucleos(t)ide Analogue Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Chronic Hepatitis B, a long-term infection of the liver caused by the hepatitis B virus. The study will use a medication called Bepirovirsen, which is given as a solution for injection. Participants in the study will either receive Bepirovirsen or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate the effectiveness and safety of Bepirovirsen in achieving a functional cure for individuals with chronic hepatitis B who are already being treated with nucleos(t)ide analogues, a type of medication that helps control the virus. The study will last for 24 weeks, during which participants will receive Bepirovirsen with initial higher doses to help achieve the desired treatment effect. The goal is to see if Bepirovirsen can help reduce the virus to very low levels or eliminate it altogether, allowing participants to stop their current hepatitis B treatment.

Throughout the study, participants will be closely monitored to ensure their safety and to assess how well the treatment is working. The study aims to provide valuable information on whether Bepirovirsen can be an effective treatment option for people with chronic hepatitis B, potentially leading to a new way to manage this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate.

    You will undergo initial assessments to confirm eligibility, including blood tests to check your hepatitis B virus (HBV) levels and liver function.

  2. Step 2

    Treatment initiation

    If eligible, you will begin treatment with either bepirovirsen or a placebo. The medication is administered as a solution for injection under the skin.

    The treatment will last for 24 weeks, with specific loading doses designed to help achieve a functional cure of chronic hepatitis B.

  3. Step 3

    Regular monitoring

    Throughout the treatment period, you will have regular visits to monitor your health and the effects of the medication. This includes blood tests to measure HBV levels and liver function.

    You will be asked to report any side effects or changes in your health during these visits.

  4. Step 4

    Treatment completion

    After completing the 24-week treatment, you will stop taking the medication. Your health will continue to be monitored to assess the long-term effects of the treatment.

    The goal is to achieve a functional cure, meaning the virus is no longer active in your body without the need for ongoing medication.

  5. Step 5

    Follow-up period

    You will have follow-up visits for 24 weeks after stopping the treatment. These visits will help determine if the treatment was successful in achieving a functional cure.

    During this period, you will not receive any rescue medication unless necessary.

Who can join the trial?

7 criteria

  • Participants must have had a documented chronic Hepatitis B (HBV) infection for at least 6 months before the screening.
  • Participants must be currently receiving stable nucleos(t)ide analogue (NA) therapy, which means no changes to their NA treatment for at least 6 months before the screening and no planned changes during the study.
  • The concentration of Hepatitis B surface antigen (HBsAg) in the blood must be more than 100 IU/mL but less than or equal to 3000 IU/mL. HBsAg is a protein on the surface of the Hepatitis B virus.
  • The concentration of Hepatitis B virus DNA in the blood must be adequately suppressed, meaning it should be less than 90 IU/mL. HBV DNA is the genetic material of the Hepatitis B virus.
  • The level of alanine aminotransferase (ALT) in the blood must be less than or equal to 2 times the upper limit of normal (ULN). ALT is an enzyme that helps break down proteins and is a marker of liver health.
  • Participants must be willing and able to stop their NA treatment according to the study protocol.
  • Both male and female participants are eligible.

Who cannot join the trial?

4 criteria

  • Patients with **Hepatitis B** who are not on **NA treatment** (a type of medication for Hepatitis B) cannot participate.
  • Patients with a **baseline HBsAg** level higher than 3000 IU/mL are excluded. **HBsAg** is a protein on the surface of the Hepatitis B virus.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population are not eligible for the study.
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Investigated drugs

Bepirovirsen is a medication being studied for its potential to help people with chronic Hepatitis B. It is designed to work by targeting the virus that causes the infection, with the goal of reducing the virus to very low levels or even eliminating it from the body. This medication is being tested to see if it can help achieve what is known as a "functional cure," meaning that the virus is controlled so well that it no longer causes harm, even if it is not completely gone. The study is looking at how effective and safe this treatment is for people who are already receiving other treatments for Hepatitis B.

What is already known about the treatment

Bepirovirsen – Bepirovirsen is administered as an injection and is currently being studied in clinical trials for its effectiveness and safety in treating chronic Hepatitis B. It is in the experimental phase and not yet widely available in medical practice. The main therapeutic use of Bepirovirsen is to help achieve a functional cure for chronic Hepatitis B in patients already receiving other antiviral treatments. At the molecular level, Bepirovirsen works by targeting and reducing the levels of viral proteins, which helps the immune system to better control the infection. It is classified as an antiviral medication.

Investigated diseases

Hepatitis B, Chronic – Chronic Hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus. It begins with an initial acute phase, which may or may not present symptoms. If the virus is not cleared from the body, it progresses to a chronic phase, where the virus remains in the liver. Over time, this can lead to inflammation and damage to liver cells. The disease can progress slowly, often over decades, and may lead to liver scarring. In some cases, it can result in more severe liver damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504239-41-00Protocol code202009Estimated enrolment912 patientsSponsorGlaxosmithkline Research & Development Limited

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