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Study on Safety and Efficacy of Bepirovirsen and Drug Combination for Chronic Hepatitis B in Patients on Nucleos(t)ide Analogue Therapy

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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 involves a new treatment approach using a medication called GSK3228836, which is an anti-sense oligonucleotide. This type of medication is designed to target and interfere with the virus's genetic material, potentially reducing its ability to multiply. Following this, participants will receive a targeted immunotherapy called GSK3528869A, which aims to boost the body's immune response against the virus. The study also includes patients who are already receiving a type of medication known as nucleos(t)ide analogue therapy, which helps to control the virus.

The purpose of the study is to evaluate the safety and effectiveness of this sequential treatment in patients with Chronic Hepatitis B who are stable on their current therapy. Participants will be randomly assigned to receive either the new treatment or a placebo. The study will monitor how well the treatment works in reducing the virus and improving the immune response, as well as any side effects that may occur. The treatment will be administered through injections, with GSK3228836 given subcutaneously (under the skin) and GSK3528869A given intramuscularly (into the muscle).

Throughout the study, participants will have regular check-ups to assess their health and the treatment's impact on the virus. The study aims to provide valuable information on whether this new treatment approach can offer a better way to manage Chronic Hepatitis B and improve patient outcomes. The trial is expected to continue until early 2026, allowing researchers to gather comprehensive data on the treatment's long-term effects.

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

    Initial treatment phase

    The initial phase involves the administration of the medication GSK3228836. This medication is given through an injection under the skin, known as subcutaneous use.

    The purpose of this phase is to evaluate the safety and effectiveness of the treatment in patients with chronic Hepatitis B who are stable on their current therapy.

  2. Step 2

    Follow-up treatment phase

    Following the initial treatment, the next phase involves the administration of GSK3528869A. This medication is given through an injection into the muscle, known as intramuscular use.

    This phase aims to assess the immune response and further evaluate the safety and effectiveness of the treatment.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess any side effects and the overall health of the participant.

    Participants are required to attend follow-up visits to evaluate the treatment's impact on their condition and to ensure their safety.

  4. Step 4

    Completion of trial

    The trial is expected to conclude by February 2026.

    Upon completion, participants will undergo a final assessment to determine the long-term effects and benefits of the treatment.

Who can join the trial?

11 criteria

  • Participants must be able and willing to follow the study requirements, such as completing diary cards and attending follow-up visits.
  • Participants must provide written or witnessed/thumb-printed informed consent before any study-specific procedures are performed.
  • Participants must be between 18 and 65 years old at the time of signing the informed consent. In South Korea, participants must be between 19 and 65 years old.
  • Participants can be either positive or negative for **HBeAg**, a protein associated with the hepatitis B virus.
  • Participants must have a documented **chronic HBV infection** for at least 6 months before screening and be stable on **NA therapy** (nucleos(t)ide analog therapy) with no changes to their treatment regimen for at least 6 months before screening and no planned changes during the study.
  • Participants must be receiving treatment with a **NA** that has a high barrier to resistance, such as entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide.
  • Participants must have **Alanine Transaminase (ALT)** levels that are no more than 2 times the upper limit of normal, documented in approximately the last 6 months. ALT is an enzyme that helps assess liver health.
  • Participants must have a plasma or serum **HBsAg** concentration greater than 100 IU/mL. HBsAg is a surface antigen of the hepatitis B virus.
  • Participants must have adequately suppressed **HBV DNA** levels, defined as less than 90 IU/mL in plasma or serum.
  • Male participants must agree to refrain from donating sperm and either remain abstinent from heterosexual intercourse or use a male condom during the study and for at least 90 days after the last dose of the study intervention. They should also be advised that their female partner should use a highly effective method of contraception.
  • Female participants must not be pregnant or breastfeeding and must either not be of childbearing potential or, if they are, use a highly effective contraceptive method with a failure rate of less than 1% per year during the study and for at least 90 days after the last dose of the study treatment.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a stable condition of **Chronic Hepatitis B** while on **NA therapy** (a type of medication used to treat hepatitis B) cannot participate.
  • Participants who are not within the specified age range for the study are excluded.
  • People who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
  • Individuals who do not meet the gender requirements for the study cannot take part.
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Investigated drugs

  • GSK3228836

    is an anti-sense oligonucleotide designed to target and reduce the levels of the virus in patients with chronic Hepatitis B. It works by interfering with the virus's ability to replicate, helping to control the infection.

  • GSK3528869A

    is a targeted immunotherapy for chronic Hepatitis B. This therapy aims to boost the body's immune response against the Hepatitis B virus, helping the immune system to better recognize and fight the infection.

  • Nucleos(t)ide Analogue (NA) Therapy

    is a standard treatment for chronic Hepatitis B that helps to suppress the virus. It works by interfering with the virus's ability to multiply, reducing the amount of virus in the body and helping to prevent liver damage.

What is already known about the treatment

  • GSK3228836

    This medication is administered as an injection and is currently being studied in clinical trials for its potential use in treating chronic Hepatitis B. It is an anti-sense oligonucleotide, which means it works by binding to specific RNA molecules to prevent the production of proteins necessary for the virus to replicate. This medication is still under investigation, and its safety and effectiveness are being evaluated in combination with other treatments.

  • GSK3528869A

    This medication is also administered as an injection and is part of ongoing clinical trials aimed at treating chronic Hepatitis B. It is a targeted immunotherapy, designed to enhance the body's immune response against the Hepatitis B virus. The medication is being tested for its safety and efficacy when used sequentially with GSK3228836 in patients already receiving nucleos(t)ide analogue therapy.

Investigated diseases

Hepatitis B, Chronic – Chronic Hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus. It occurs when the virus remains in the body for more than six months, leading to ongoing liver inflammation. Over time, this can result in liver damage, including scarring (cirrhosis) and potentially liver cancer. The disease is often asymptomatic in its early stages, but some individuals may experience fatigue, abdominal pain, and jaundice. As the disease progresses, symptoms may become more pronounced, and liver function can be significantly impaired. Chronic Hepatitis B is primarily spread through contact with infectious body fluids, such as blood or semen.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512352-38-00Protocol code217023Estimated enrolment205 patientsSponsorGlaxoSmithKline Biologicals

sourced from the EU Clinical Trials Register and site verification

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