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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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Oncopole Claudius Regaud Toulouse France
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Di Pisa Pisa Italy
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Centre Hospitalier Universitaire De Rennes Rennes France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Ezswyuk Udkxwjsxoupp Mxibxpg Ccjswsb Rmpomsbgm (smwrzfl Msl Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
05.12.2022
France France
Not recruiting
05.12.2022
Germany Germany
Not recruiting
05.12.2022
Italy Italy
Not recruiting
05.12.2022
Romania Romania
Not recruiting
05.12.2022
The Netherlands The Netherlands
Not recruiting
05.12.2022

Trial locations

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.

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 ID:
2024-512203-40-00
Protocol code:
VIR-CHDV-V201
NCT ID:
NCT05461170
Trial Phase:
Therapeutic exploratory (Phase II)

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