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Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide 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 a condition known as Chronic Hepatitis D Virus (HDV) Infection. The study is investigating a combination of two treatments, Tobevibart and Elebsiran, to see how effective they are in treating this infection. These treatments are being tested in people who have previously been treated with another medication called Bulevirtide but have not achieved the desired results.

The purpose of the study is to evaluate how well the combination of Tobevibart and Elebsiran works in reducing the virus in the body. Participants in the study will receive these treatments through injections under the skin. The study will be conducted over a period of time, with regular check-ups to monitor the effects of the treatment. The study will also look at how the treatment affects liver health and any side effects that may occur.

Participants will be monitored for changes in their health, including the amount of virus in their blood and the condition of their liver. The study aims to provide valuable information on the effectiveness and safety of the combination therapy for people with Chronic Hepatitis D Virus Infection who have not responded well to previous treatments.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, health status, and current treatment with bulevirtide for at least 24 weeks.

    Blood tests are performed to measure HDV RNA levels, which should be at least 500 IU/mL. Liver health is assessed to ensure noncirrhotic or compensated cirrhotic liver disease.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of tobevibart and elebsiran, administered through subcutaneous injections. This means the medication is injected under the skin.

    The specific dosage and frequency of these medications are determined by the study protocol and are explained during this phase.

  3. Step 3

    Ongoing treatment and monitoring

    Regular visits are scheduled to monitor health and the effectiveness of the treatment. Blood tests are conducted to measure changes in HDV RNA and liver function.

    Participants are observed for any side effects or adverse events. Adjustments to the treatment plan may be made based on these observations.

  4. Step 4

    Evaluation at week 24

    At week 24, a comprehensive evaluation is conducted to assess the reduction in HDV RNA levels. The goal is to achieve levels below the limit of detection.

    Liver function tests and other health assessments are performed to ensure the treatment is working effectively.

  5. Step 5

    Long-term follow-up

    Participants continue to receive treatment and are monitored at regular intervals, including weeks 48 and 96, to track long-term effects and health outcomes.

    The study aims to observe the sustained response and any potential long-term benefits or risks associated with the treatment.

  6. Step 6

    Treatment interruption and final evaluation

    In the later stages, treatment may be systematically interrupted to evaluate the body's response without medication. This occurs around week 96.

    Final evaluations are conducted up to week 240 to assess the long-term impact of the treatment and any changes in health status.

Who can join the trial?

6 criteria

  • Adult men and women aged 18 to 70 years at the time of signing the consent form.
  • Have a level of HDV RNA (a measure of the virus in the blood) of at least 500 IU/mL at the start of the study.
  • Have been receiving BLV 2 mg (a type of medication) as a subcutaneous injection (under the skin) once daily for at least 24 weeks before the first day of the study.
  • Have either noncirrhotic (no severe liver scarring) or compensated cirrhotic (liver scarring that is not causing severe symptoms) liver disease at the start of the study.
  • Have a Body Mass Index (BMI) between 18 kg/m² and 40 kg/m². BMI is a measure of body fat based on height and weight.
  • Be on NRTI therapy (a type of medication for hepatitis B) for at least 12 weeks before the first day of the study, or have a level of HBV DNA (a measure of hepatitis B virus in the blood) less than 20 IU/mL at the start of the study. Participants must be on one of the following NRTI therapies: tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of hepatitis infection other than Chronic Hepatitis D Virus (HDV) Infection cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not willing or able to follow the study procedures and requirements cannot participate.
  • Patients who have any other medical condition that the study doctors think might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have a history of substance abuse that could interfere with the study cannot participate.
  • Patients who have a known allergy or adverse reaction to the study medications cannot participate.
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Investigated drugs

  • Tobevibart

    is a medication being studied for its ability to help people with chronic HDV infection. It is used in combination with another medication to see if it can better control the virus in people who have already been treated with another drug called Bulevirtide but still have the virus in their system. The goal is to see if Tobevibart can help reduce the amount of virus in the body and improve the health of the liver.

  • Elebsiran

    is another medication used in this study alongside Tobevibart. It is being tested to see if it can help people with chronic HDV infection achieve a state where the virus is no longer actively affecting their body. This is especially important for people who have been treated before but still have the virus. The combination of Elebsiran with Tobevibart is being evaluated to see if it can provide better results in controlling the infection and improving liver health.

What is already known about the treatment

  • Tobevibart

    Tobevibart is administered orally and is part of a combination therapy aimed at treating chronic Hepatitis D Virus (HDV) infection. It is currently being studied in clinical trials to assess its effectiveness and safety, particularly in patients who have not achieved viral suppression with existing treatments like Bulevirtide. The main therapeutic indication for Tobevibart is chronic HDV infection. At the molecular level, Tobevibart works by inhibiting viral replication, helping to reduce the viral load in the body. It is classified pharmacologically as an antiviral medication.

  • Elebsiran

    Elebsiran is also administered orally and used in combination with Tobevibart to treat chronic Hepatitis D Virus (HDV) infection. It is under investigation in clinical trials to determine its efficacy and safety, especially in patients who have previously been treated with Bulevirtide but have not achieved viral suppression. The primary therapeutic use of Elebsiran is for chronic HDV infection. On a molecular level, Elebsiran functions by targeting specific viral components to prevent the virus from multiplying. It is classified as an antiviral drug.

Investigated diseases

Chronic Hepatitis D Virus (HDV) Infection – This disease is a liver infection caused by the hepatitis D virus, which requires the presence of hepatitis B virus to replicate. It is characterized by inflammation of the liver, which can lead to liver damage over time. The progression of the disease can vary, with some individuals experiencing mild symptoms, while others may develop severe liver complications. Over time, chronic HDV infection can lead to fibrosis, cirrhosis, and liver failure. The disease is primarily spread through contact with infected blood or bodily fluids. Managing the disease involves monitoring liver function and preventing further liver damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519282-22-00Protocol codeVIR-CHDV-V205Estimated enrolment150 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.

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