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Long-term Study on Treatment Response in Chronic Hepatitis B Patients Using Bepirovirsen

Fast replyInvestigationalNo placebo
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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 long-term effects of a treatment for Chronic Hepatitis B, a liver infection caused by the hepatitis B virus. The treatment being evaluated is called bepirovirsen, which is administered as a solution for injection. This study is designed to observe how well the treatment response lasts over time in participants who have previously been treated with bepirovirsen, with or without additional nucleos(t)ide therapy, which is another type of medication used to manage hepatitis B.

The purpose of the study is to understand the durability of the treatment response. Participants in this study will have their health monitored over a period of time to see how their condition progresses after receiving bepirovirsen. The study will involve regular check-ups to assess the levels of certain markers in the blood that indicate the presence of the hepatitis B virus and the body's response to the treatment. These markers include HBsAg, which is a protein on the surface of the hepatitis B virus, and HBV DNA, which is the genetic material of the virus.

Throughout the study, researchers will also look for any signs of the virus returning or any need for additional medication. The study aims to provide valuable information on how effective bepirovirsen is in maintaining a long-term response in people with chronic hepatitis B, helping to improve future treatment strategies for this condition.

The research process

The trial runs in 4 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, participants are required to have previously participated in a bepirovirsen treatment study for chronic hepatitis B.

    Participants must have achieved specific treatment responses in their previous study to be eligible for this follow-up study.

  2. Step 2

    Treatment administration

    The study involves the administration of bepirovirsen, which is a solution for injection given subcutaneously.

    Participants who are on stable nucleos(t)ide analog (NA) therapy may need to cease their NA treatment according to a specific schedule.

  3. Step 3

    Monitoring and follow-up

    Participants will be monitored for the long-term durability of their treatment response.

    Regular assessments will be conducted to measure levels of hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV) DNA, and other relevant markers.

  4. Step 4

    End of study

    The study is estimated to conclude by March 24, 2029.

    Participants will have their final assessments to evaluate the outcomes of the treatment and any long-term effects.

Who can join the trial?

12 criteria

  • Participants must have **Chronic Hepatitis B**, which is a long-lasting infection of the liver caused by the hepatitis B virus.
  • Participants who are currently on stable **NA** (nucleos(t)ide analogues, a type of medication) must be willing and able to stop their NA treatment according to the study's schedule.
  • Participants must be capable of giving informed consent, meaning they understand the study and agree to participate.
  • Participants from specific previous studies (B-Clear, B-Together, B-Fine) must have received at least one dose of **bepirovirsen** (a study medication) and either:
    • Achieved a **PSPO** (primary study protocol objective) and maintained a response until the end of their previous study, or
    • Shown a reduction in **HBsAg** (hepatitis B surface antigen, a protein on the surface of the virus) and **HBV DNA** (the virus's genetic material) for 24 weeks after stopping treatment, without needing additional medication, and maintained this until the end of their previous study.
    • Participants from other specific studies (B-Well 1 & 2) must have received at least one dose of bepirovirsen (or a placebo) and either:
      • Stopped NA treatment at Week 48 in their previous study and achieved certain levels of HBsAg and HBV DNA by the end of the study (Week 96), or
      • Met criteria to stop NA treatment at Week 48 but continued treatment, maintaining certain levels of HBsAg and HBV DNA by the end of the study (Week 72), or
      • Did not meet criteria to stop NA treatment in their previous study but achieved certain levels of HBsAg and HBV DNA by the end of the study (Week 72).
      • Participants from another specific study (TH HBV ASO-001) must have received at least one dose of bepirovirsen and either:
        • Achieved certain levels of HBsAg and HBV DNA at specific weeks in their previous study and maintained these levels by the end of the study, or
        • Did not achieve these levels at specific weeks but did so by the end of the study.
        • Participants can be of any gender.
        • The study includes vulnerable populations, meaning groups that may need special protection or consideration.

Who cannot join the trial?

6 criteria

  • Patients with other serious liver diseases besides Chronic Hepatitis B cannot participate. This means if you have another liver condition, you may not be eligible.
  • Patients who have had a liver transplant are not eligible. A liver transplant is when a damaged liver is replaced with a healthy one from a donor.
  • Patients who are pregnant or breastfeeding cannot take part in the study. This is to ensure the safety of both the mother and the baby.
  • Patients with a history of alcohol or drug abuse may be excluded. This refers to using alcohol or drugs in a way that is harmful to your health.
  • Patients who are unable to follow the study procedures or attend study visits may not be eligible. This means if you cannot commit to the study schedule, you might not be able to participate.
  • Patients with certain medical conditions that could interfere with the study results may be excluded. This means if you have a health issue that could affect the study, you might not be eligible.
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Investigated drugs

  • Bepirovirsen

    is a medication being studied for its effects on chronic hepatitis B. It is designed to help reduce the amount of hepatitis B virus in the body. The trial aims to evaluate how well the treatment response lasts over time in participants who have previously received bepirovirsen.

  • Nucleos(t)ide Therapy

    refers to a group of antiviral medications commonly used to treat chronic hepatitis B. These medications work by interfering with the virus's ability to replicate, helping to control the infection and reduce liver damage. The study includes participants who have been treated with these therapies to assess the long-term effects of their treatment.

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 for its effectiveness in treating chronic hepatitis B. The main therapeutic indication for bepirovirsen is to manage and potentially improve the long-term treatment response in individuals with chronic hepatitis B. At the molecular level, bepirovirsen works by targeting and reducing the levels of viral RNA, which helps to decrease the replication of the hepatitis B virus. It is classified as an antiviral medication.

Investigated diseases

Chronic Hepatitis B – Chronic Hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus. It can lead to inflammation and damage to liver cells over time. The disease progresses slowly, often without noticeable symptoms in the early stages. As it advances, individuals may experience fatigue, jaundice, and abdominal discomfort. The virus can remain in the body for years, potentially leading to liver cirrhosis or liver cancer. Regular monitoring is essential to manage the condition and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506867-33-01Protocol code206882Estimated enrolment378 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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