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Study on the Effects of VIR-2218 and VIR-3434 for Patients with Chronic Hepatitis D 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 evaluate two investigational therapies, Vir-2218 and Vir-3434. Vir-2218 is a solution for injection containing the active substance elebsiran, which is a type of nucleic acid. Vir-3434 is also a solution for injection, containing the active substance tobevibart, a protein known as a human immunoglobulin G1 (IgG1) monoclonal antibody.

The purpose of the study is to assess how effective and safe these treatments are for people with chronic HDV infection. Participants will receive the treatments through injections under the skin. The study will monitor the participants over a period of time to observe any changes in their health and to check for any side effects. The study aims to see if the treatments can reduce the amount of virus in the body and improve liver function.

Throughout the study, participants will have regular check-ups to track their progress. The study will look at how the treatments affect the virus levels and liver health at different points in time. This research is important for understanding how these new therapies might help people with chronic HDV infection in the future.

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

    Joining the study

    Upon joining the study, participants are required to provide informed consent, confirming their understanding and agreement to comply with the study requirements and restrictions.

  2. Step 2

    Initial assessment

    Participants undergo an initial assessment to confirm eligibility, which includes verifying age, medical history, and current health status related to chronic hepatitis D virus infection.

  3. Step 3

    Treatment initiation

    Participants begin treatment with two investigational therapies: VIR-2218 and VIR-3434. Both medications are administered as a solution for injection under the skin (subcutaneous use).

    The specific dosage and frequency of administration are determined by the study protocol and are tailored to each participant's needs.

  4. Step 4

    Ongoing monitoring

    Participants attend regular study visits for monitoring. These visits include assessments of health status, blood tests to measure hepatitis D virus levels, and evaluations of liver function.

    Monitoring occurs at specified intervals, including weeks 12, 24, 48, 72, 96, 144, and 192, to track changes in virus levels and liver health.

  5. Step 5

    Evaluation of treatment effects

    The study evaluates the effectiveness of the treatments by measuring the proportion of participants with undetectable virus levels or significant reductions in virus levels at various time points.

    The study also monitors for any adverse effects that may arise during the treatment period.

  6. Step 6

    Completion of study participation

    Participants complete their involvement in the study after the final assessment, which occurs up to week 192.

    The study aims to gather comprehensive data on the long-term effects and safety of the treatments.

Who can join the trial?

13 criteria

  • Participants must be at least 18 years old (or the age of legal consent, whichever is older) and younger than 70 years at the time of screening.
  • Participants must have a **chronic HBV infection**, which means they have tested positive for certain markers of the virus on two occasions at least 6 months apart.
  • Participants must have been on a locally approved **NRTI therapy** (a type of medication for HBV) for at least 12 weeks before the start of the study.
  • Participants must have a certain level of **HBsAg** (a marker of HBV infection) in their blood at screening.
  • Participants must have tested positive for **HDV antibodies** for at least 6 months before screening and have a certain level of **HDV RNA** (a marker of HDV infection) in their blood at screening.
  • Participants must have a certain level of **serum alanine aminotransferase (ALT)**, which is a liver enzyme, in their blood. It should be above the normal limit but less than five times the normal limit.
  • Participants must have a **Body Mass Index (BMI)** between 18 and 40 kg/m². BMI is a measure of body fat based on height and weight.
  • Female participants must have a negative pregnancy test or be confirmed as postmenopausal, which means they have not had a menstrual period for 12 months without another medical reason.
  • Women of childbearing potential must have a negative pregnancy test at screening and on the first day of the study, must not be breastfeeding, and must agree to use highly effective contraception methods from 14 days before the study starts until 48 weeks after the last dose of the study medication.
  • Female participants must agree not to donate eggs or undergo in vitro fertilization from the time the study starts until 48 weeks after the last dose of the study medication.
  • Male participants with female partners who can become pregnant must agree to use contraception methods from the time the study starts until 48 weeks after the last dose of the study medication. This can include having had a vasectomy, using a condom, or ensuring their partner uses contraception.
  • Male participants must agree not to donate sperm from the time the study starts until 48 weeks after the last dose of the study medication.
  • Participants must be able to give signed informed consent, which means they understand and agree to the study's requirements and restrictions.

Who cannot join the trial?

7 criteria

  • Patients who have any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of substance abuse that could affect their ability to follow the study procedures.
  • Patients who have received certain treatments for HDV infection recently.
  • Patients who have any condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • VIR-2218

    is a medication being studied for its potential to treat chronic Hepatitis D Virus (HDV) infection. It is designed to help reduce the levels of the virus in the body, potentially improving liver health and reducing symptoms associated with the infection.

  • VIR-3434

    is another medication involved in the study, also aimed at treating chronic HDV infection. This medication works by targeting the virus, helping to control its spread and impact on the liver. The study is evaluating how well this medication works and how safe it is for patients.

What is already known about the treatment

  • VIR-2218

    This medication is administered through injection and is currently being studied in clinical trials for its effectiveness in treating chronic Hepatitis D Virus (HDV) infection. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for VIR-2218 is to reduce the viral load in patients with chronic HDV. At the molecular level, it works by targeting and degrading viral RNA, thereby inhibiting the replication of the virus. It is classified as an antiviral agent.

  • VIR-3434

    This medication is also administered via injection and is being evaluated in clinical trials for its potential to treat chronic Hepatitis D Virus (HDV) infection. Like VIR-2218, it is not yet approved for general medical use. The primary therapeutic indication for VIR-3434 is to help control and reduce the effects of chronic HDV. Its mechanism of action involves binding to viral particles, preventing them from entering liver cells and thus reducing infection. It is classified as an antiviral agent.

Investigated diseases

Chronic Hepatitis D Virus (HDV) Infection – This disease is a liver infection caused by the hepatitis D virus, which only occurs in those already infected with hepatitis B. It is characterized by inflammation of the liver, which can lead to liver damage over time. The infection can be acute or chronic, with chronic cases potentially leading to more severe liver complications. Symptoms may include fatigue, jaundice, abdominal pain, and joint pain, although some individuals may remain asymptomatic. The progression of the disease can vary, with some individuals experiencing a slow progression while others may develop more serious liver issues. Chronic HDV infection requires the presence of hepatitis B virus for replication and persistence.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512203-40-00Protocol codeVIR-CHDV-V201Estimated enrolment154 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).