Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Hepatitis D Virus (HDV) Infection. The study will evaluate a combination treatment using two investigational medications, Tobevibart and Elebsiran. Tobevibart is a type of protein called a monoclonal antibody, which is designed to target specific parts of the virus. Elebsiran is a nucleic acid-based treatment that aims to interfere with the virus’s ability to replicate.

The purpose of this study is to assess how effective and safe the combination of Tobevibart and Elebsiran is for people with chronic HDV infection. Participants in the study will receive these medications through injections under the skin. The study will compare the effects of starting the treatment immediately versus delaying it. Throughout the study, participants will have regular check-ups to monitor their health and the virus’s response to the treatment.

The study will last for several years, with participants being observed at different intervals to see how the treatment affects the virus and their liver health over time. The goal is to see if the combination of Tobevibart and Elebsiran can reduce the amount of virus in the body and improve liver function. Participants will be closely monitored for any side effects or changes in their condition during the study period.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria such as age, health condition, and previous medical history related to chronic hepatitis D virus (HDV) infection.

A detailed explanation of the study, including its purpose and procedures, is provided. Consent is obtained to ensure understanding and agreement to participate.

2 baseline assessments

Baseline assessments are conducted to gather initial health data. This includes blood tests to measure HDV RNA levels and liver function tests to assess alanine aminotransferase (ALT) levels.

Additional assessments may include liver imaging to evaluate liver condition and other relevant health checks.

3 treatment initiation

The treatment phase begins with the administration of the study medications, tobevibart and elebsiran. These medications are given as injections under the skin (subcutaneous use).

The dosage and frequency of administration are determined by the study protocol, and participants are informed of the schedule.

4 regular follow-up visits

Regular follow-up visits are scheduled to monitor health and response to treatment. These visits include blood tests to measure HDV RNA and ALT levels, as well as assessments of any side effects or adverse events.

The frequency of these visits is determined by the study protocol, and participants are informed of the schedule.

5 mid-study evaluation

A mid-study evaluation is conducted to assess progress. This includes a comprehensive review of health data collected during the study, such as changes in HDV RNA and ALT levels.

Adjustments to the treatment plan may be made based on the evaluation results.

6 end of treatment phase

The treatment phase concludes after a specified duration, as outlined in the study protocol. Final assessments are conducted to evaluate the overall effectiveness and safety of the treatment.

Participants are informed of the results and any further steps, such as continued monitoring or additional treatment options.

7 long-term follow-up

Long-term follow-up visits are scheduled to monitor health after the treatment phase. These visits may continue for several years to assess the long-term effects of the treatment.

Participants are informed of the schedule and any ongoing assessments required.

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 Hepatitis D Virus (HDV) for at least 6 months before the study 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.
Must have a specific level of a liver enzyme called alanine aminotransferase (ALT) in the blood, which is higher than normal but not excessively high.
Must have a Body Mass Index (BMI) between 18 and 40. BMI is a measure of body fat based on height and weight.
Must be on certain medications for Hepatitis B Virus (HBV) for at least 12 weeks before the study or have a very low level of HBV in the blood. The medications include tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir.

Who Cannot Join the Study?

Patients who do not have a chronic Hepatitis D Virus (HDV) infection cannot participate. This means if you do not have a long-term infection with the Hepatitis D virus, you are not eligible.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population are not eligible. This refers to groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes	Bucharest	Romania
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Rennes	Rennes	France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals	Bucharest	Romania
Fundeni Clinical Institute	Bucharest	Romania
Ubatquoswmnzbajaagisn Eauci Anq	Essen	Germany
Cidapc Hqopjdmzglo Ea Ualczxhhcrkho Dr Lvmerom	Limoges	France
Gwrctq Uahqsnyxuj Ffpkwahot	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	05.06.2025
Germany	Not recruiting	05.06.2025
Romania	Not recruiting	05.06.2025

Trial locations

Investigated drugs:

Tobevibart is a medication being studied for its potential to help people with chronic HDV infection. HDV, or Hepatitis D Virus, is a serious liver infection. Tobevibart is designed to work by targeting the virus in the body, helping to reduce its effects and improve liver health. In this trial, researchers are looking at how well Tobevibart works when used together with another medication, and they are also checking to make sure it is safe for patients to use.

Elebsiran is another medication being tested in this study for people with chronic HDV infection. Like Tobevibart, Elebsiran aims to fight the virus that causes the infection. By using Elebsiran, researchers hope to see improvements in the health of the liver and a reduction in the symptoms of the infection. The study is also focused on understanding the safety of using Elebsiran in combination with Tobevibart, to ensure that this combination is safe for patients.

Investigated diseases:

Hepatitis D

Chronic Hepatitis D Virus 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 leading to cirrhosis. As the disease advances, liver function may decline, and complications such as liver stiffness and decompensated cirrhosis can occur. The infection can also increase the risk of developing hepatocellular carcinoma, a type of liver cancer. Chronic HDV infection is considered a rare disease and can significantly impact liver health over time.

Trial ID:

2024-515919-22-00

Protocol code:

VIR-CHDV-V203

NCT ID:

NCT06903338

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection

What is this study about?

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