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Study on Bepirovirsen for Patients with Chronic Hepatitis B Receiving 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 administered as a solution for injection. Participants in the study will either receive Bepirovirsen or a placebo, which is a substance with no active medication.

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.

Throughout the study, participants will be monitored to assess the impact of the treatment on their condition. The goal is to determine if Bepirovirsen can help achieve a functional cure, meaning the virus is controlled without the need for ongoing medication. This study is part of a larger effort to find effective treatments for chronic hepatitis B and improve the quality of life for those affected by 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, the participant is confirmed to have chronic hepatitis B virus (HBV) infection for at least 6 months and is currently on a stable nucleos(t)ide analogue (NA) therapy.

    The participant's HBV DNA levels are checked to ensure they are adequately suppressed, and their alanine aminotransferase (ALT) levels are within the acceptable range.

  2. Step 2

    Treatment initiation

    The participant begins treatment with bepirovirsen, administered as a solution for injection under the skin (subcutaneous use).

    The dosage is 150 mg/mL, and the treatment includes loading doses to achieve a functional cure.

  3. Step 3

    Treatment duration

    The treatment with bepirovirsen continues for a period of 24 weeks.

    During this time, the participant remains on their stable NA therapy without any changes.

  4. Step 4

    Treatment assessment

    The main objective is to assess the treatment effect of bepirovirsen in achieving a functional cure for chronic HBV infection.

    The primary endpoint is to determine if a functional cure is maintained for 24 weeks after stopping all chronic HBV treatments, including bepirovirsen, placebo, and NA, without the need for rescue medication.

  5. Step 5

    End of study

    The study is estimated to conclude by June 24, 2026.

    Participants are monitored for the primary endpoint and any potential side effects throughout the study duration.

Who can join the trial?

7 criteria

  • Participants must have a documented chronic Hepatitis B (HBV) infection for at least 6 months before the screening.
  • Participants should be currently receiving stable NA (nucleos(t)ide analogue) 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 HBsAg (Hepatitis B surface antigen) in the blood should be more than 100 IU/mL but not more than 3000 IU/mL.
  • The concentration of HBV DNA in the blood must be adequately suppressed, meaning it should be less than 90 IU/mL.
  • The level of alanine aminotransferase (ALT), an enzyme found in the liver, should be no more than 2 times the upper limit of normal (ULN).
  • 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

  • Individuals with **Hepatitis B** who are not on **NA treatment**. **NA treatment** refers to medications that help control the virus.
  • Individuals with a baseline **HBsAg** level greater than 3000 IU/mL. **HBsAg** is a protein on the surface of the Hepatitis B virus, and its level indicates the amount of virus in the blood.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Bepirovirsen is a medication being studied for its potential to help people with chronic Hepatitis B virus infection. It is being tested to see if it can provide a functional cure for those who are already receiving treatment with nucleos(t)ide analogues. The study involves using bepirovirsen for a period of 24 weeks, with initial higher doses to see if it can effectively reduce the virus in the body.

What is already known about the treatment

Bepirovirsen – Bepirovirsen is administered as an injection, typically given under the skin. It is currently being studied in clinical trials, specifically in a Phase 3 trial, to evaluate its effectiveness and safety for treating chronic Hepatitis B. The main therapeutic indication for Bepirovirsen is chronic Hepatitis B, particularly in patients already receiving nucleos(t)ide analogue treatment. At the molecular level, Bepirovirsen works by targeting and reducing the levels of viral proteins and genetic material, aiming to achieve a functional cure. It is classified pharmacologically as an antisense oligonucleotide, which means it is designed to bind to specific RNA sequences to inhibit the production of viral proteins.

Investigated diseases

Hepatitis B, Chronic – This is a long-term infection of the liver caused by the hepatitis B virus. It can lead to inflammation and damage to the liver over time. The disease progresses slowly, often without symptoms in the early stages. As it advances, it may cause symptoms such as fatigue, jaundice, and abdominal pain. Chronic hepatitis B can lead to more serious liver conditions, such as cirrhosis or liver cancer. The virus is primarily spread through contact with infectious body fluids.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504238-23-00Protocol code219288Estimated enrolment929 patientsSponsorGlaxosmithkline Research & Development Limited

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