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Study on the Effects of Tobevibart and Elebsiran Compared to Bulevirtide for Patients with Chronic Hepatitis D Virus Infection

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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 treatments for Chronic Hepatitis D Virus (HDV) Infection. The study will compare the effectiveness and safety of a combination therapy using two medications, Tobevibart and Elebsiran, against another medication called Bulevirtide. Tobevibart is a type of protein that acts as a monoclonal antibody, which means it is designed to target specific parts of the virus. Elebsiran is a nucleic acid-based treatment, which means it works at the genetic level to interfere with the virus's ability to replicate. Bulevirtide is a protein-based treatment that is already used for managing HDV infection.

The purpose of this study is to evaluate how well the combination of Tobevibart and Elebsiran works compared to Bulevirtide in reducing the amount of virus in the body and to assess the safety of these treatments. Participants in the study will receive either the combination therapy or Bulevirtide and will be monitored over a period of time to see how their condition changes. The study will also look at how the treatments affect the liver and overall health of the participants.

Participants will receive the treatments through subcutaneous injections, which means the medication is injected under the skin. The study will take place over several weeks, with regular check-ups to monitor the participants' health and the effectiveness of the treatments. The goal is to find out which treatment is more effective in managing Chronic Hepatitis D Virus (HDV) Infection and to ensure that the treatments are safe for the participants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, medical staff will review your medical history and perform necessary tests to confirm your eligibility for the trial. This includes checking for a positive hepatitis D virus (HDV) antibody or HDV RNA result and ensuring your liver condition is suitable for participation.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups. One group will receive a combination of tobevibart and elebsiran, while the other group will receive bulevirtide. All medications are administered through subcutaneous injection, which means they are injected under the skin.

  3. Step 3

    Medication administration

    If you are in the tobevibart and elebsiran group, you will receive these medications as a solution for injection. If you are in the bulevirtide group, you will receive it as a powder that is mixed into a solution for injection. The frequency and dosage will be explained to you by the medical staff.

  4. Step 4

    Regular follow-up visits

    You will have regular follow-up visits with the medical team. These visits are crucial for monitoring your health and the effectiveness of the treatment. Blood tests and other assessments will be conducted to track the virus levels and liver function.

  5. Step 5

    Treatment interruption

    At a certain point in the study, there may be a planned interruption of the tobevibart and elebsiran treatment. This is to evaluate the sustained virologic response, which means checking if the virus remains at low levels even after stopping the medication.

  6. Step 6

    Final assessment

    The study will conclude with a final assessment to evaluate the overall effectiveness and safety of the treatments. This includes checking the virus levels and any side effects experienced during the trial.

Who can join the trial?

5 criteria

  • Adult men and women aged 18 to 70 years at the time of signing the consent form.
  • Must have a positive test for HDV (Hepatitis D Virus) for at least 6 months before the study starts and a certain level of the virus in the blood at the start of the study.
  • Must have liver disease that is either not severe or is stable and under control at the start of the study.
  • Body Mass Index (BMI) must be between 18 and 40. BMI is a measure of body fat based on height and weight.
  • Must be on a specific type of medication called NRTI (Nucleoside Reverse Transcriptase Inhibitors) for Hepatitis B Virus (HBV) for at least 12 weeks before the study starts, or have a very low level of HBV in the blood at the start of the study. The NRTI medication must be one of the following: tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir.

Who cannot join the trial?

9 criteria

  • Patients who do not have Chronic Hepatitis D Virus (HDV) Infection cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fit the required age group.
  • Patients who are not part of the specified clinical trial group cannot participate. The specific group is not detailed here, but it is important to verify if you belong to the required group.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. It is important to discuss your medical history with the study team.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have a history of substance abuse that could interfere with the study cannot participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
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Investigated drugs

  • Tobevibart

    is a medication being studied for its potential to help people with chronic HDV infection. It is part of a combination therapy being tested to see if it can reduce the amount of virus in the body. This medication is being evaluated to understand how well it works and how safe it is for patients.

  • Elebsiran

    is another medication used in combination with Tobevibart in this clinical trial. It is being tested to see if it can help achieve a sustained virologic response, which means keeping the virus at very low levels or undetectable in the body. The study aims to find out if this combination can effectively manage the infection and improve patient outcomes.

  • Bulevirtide

    is a medication that is already used to treat chronic HDV infection. In this trial, it serves as a comparison to the new combination therapy of Tobevibart and Elebsiran. The study is looking at how well Bulevirtide works in reducing the virus and its safety profile compared to the new combination therapy.

What is already known about the treatment

  • Tobevibart

    Tobevibart is administered as part of a combination therapy for chronic Hepatitis D Virus (HDV) infection. It is currently being studied in clinical trials to assess its effectiveness and safety. The main therapeutic use of Tobevibart is to help control HDV infection. At the molecular level, it works by interfering with the virus's ability to replicate, thereby reducing the viral load in the body. Tobevibart is classified as an antiviral medication.

  • Elebsiran

    Elebsiran is used in combination with Tobevibart for treating chronic HDV infection. It is under investigation in clinical trials to determine its efficacy and safety. The primary therapeutic indication for Elebsiran is to assist in managing HDV infection. It acts at the molecular level by targeting specific viral components, which helps to prevent the virus from multiplying. Elebsiran falls under the category of antiviral drugs.

  • Bulevirtide

    Bulevirtide is administered to patients with chronic HDV infection and is being compared to the combination therapy of Tobevibart and Elebsiran in clinical trials. Its main therapeutic role is to help control HDV infection. Bulevirtide works by blocking the entry of the virus into liver cells, thereby reducing the infection's progression. It is classified as an antiviral medication.

Investigated diseases

Chronic Hepatitis D Virus (HDV) Infection – Chronic Hepatitis D Virus (HDV) Infection is a liver disease caused by the hepatitis D virus, which requires the presence of hepatitis B virus (HBV) to replicate. The disease progresses as the virus infects liver cells, leading to inflammation and damage over time. This can result in liver fibrosis, where scar tissue forms in the liver, potentially progressing to cirrhosis, a severe scarring of the liver. As the disease advances, liver function may decline, affecting the body's ability to process nutrients and filter toxins. Patients may experience symptoms such as fatigue, jaundice, and abdominal discomfort. The progression of the disease can vary, with some individuals experiencing a more rapid decline in liver function than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520062-54-00Protocol codeVIR-CHDV-V206Estimated enrolment100 patientsSponsorVir Biotechnology Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).