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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

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
IRCCS Humanitas Research Hospital Rozzano Italy
Oncopole Claudius Regaud Toulouse France
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hopital Beaujon Clichy France
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Bucharest Romania
SGS Belgium Edegem Belgium
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital General Universitario De Valencia Valencia Spain
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
University Childrens Hospital Queen Fabiola Brussels Belgium
Fundeni Clinical Institute Bucharest Romania
Uiymfvqdbjcjlxfjiljaf Eyfhe Anl Essen Germany
Habjcysa Uiooemolkfbro Myoluow Dh Vulsuurxif Santander Spain
Cgfibb Hiugxaakkut Eb Uhacwaocequjp Du Lvddjiw Limoges France
Eafqnoa Utaogqebkjlo Mccdmjq Cxpagws Rtivtzcnm (uumkdqi Mab Rotterdam The Netherlands
Aognogq Opywgbjmyhb Ueqqqpcwtecxw Cbtvawohrdsl Doffh Sdjjet E Dvyfn Svtqjqk Di Tfobdo Turin Italy
Akfpmaqxt Urf Amsterdam The Netherlands
Gmyrmv Uqxxfydpse Fnwhxlycd Frankfurt Germany
Ugezhbojig Og Acsbjky Edegem Belgium
Fksafhhpl Phlp Lu Izuenieoeydyj Bmziahnqb Dhd Hsyrqbxt Uzzzalfrerkhk Lp Pvn Madrid Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
09.07.2025
Bulgaria Bulgaria
Not recruiting
09.07.2025
France France
Not recruiting
09.07.2025
Germany Germany
Not recruiting
09.07.2025
Italy Italy
Not recruiting
09.07.2025
Romania Romania
Not recruiting
09.07.2025
Spain Spain
Not recruiting
09.07.2025
The Netherlands The Netherlands
Not recruiting
09.07.2025

Trial locations

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.

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 ID:
2024-520062-54-00
Protocol code:
VIR-CHDV-V206
NCT ID:
NCT07142811
Trial Phase:
Therapeutic exploratory (Phase II)

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