Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection

This clinical trial is looking for people aged 18 to 70 in the UK who have a long-lasting liver infection called chronic hepatitis delta virus (HDV). The study aims to compare how well two new medicines, Tobevibart and Elebsiran (when given together), work compared to an existing treatment called Bulevirtide. These treatments are designed to help control the HDV infection and potentially improve liver health. Scientists want to understand if the new combination treatment is a safe and effective option. Taking part would mean receiving one of these study treatments and having regular check-ups to monitor your health and the virus. This research helps us find better ways to manage HDV infection for others in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Vir Biotechnology, Inc.

Enrolment target

100

Start

05 Aug 2025

Estimated completion

01 Jul 2030

Viral Hepatitis

What is this study about?

This study is about a long-lasting liver infection called Hepatitis Delta Virus, or HDV for short. This virus can cause serious liver problems over time. Currently, there are limited treatments, so doctors and scientists are always looking for better and safer options for patients.

In this particular study, they are testing two new medicines, Tobevibart and Elebsiran, which are given together as a combination treatment. They want to see how these new medicines compare to a treatment that is already available, called Bulevirtide. The main goal is to find out which treatment, or combination, is best at controlling the HDV virus in people and helping their liver stay healthy.

By taking part, you would be helping researchers learn more about how to treat HDV infection. This knowledge could lead to new and improved treatments for many other people living with this condition in the future. It's an important step in finding the best ways to manage HDV.

Key takeaways

This study is for adults with long-term Hepatitis Delta Virus (HDV) infection.
It compares two new medicines combined (Tobevibart + Elebsiran) with an existing medicine (Bulevirtide).
The goal is to find better ways to control the HDV virus and protect the liver.
Participants will receive study medication and have regular health check-ups.
Joining could offer access to new treatments and helps future patients.
You can withdraw from the study at any time without affecting your usual care.

Who may be eligible?

To join this study, you need to be between 18 and 70 years old. You must have chronic HDV infection, which means you've tested positive for the virus for at least six months and have a certain level of the virus in your blood when you're checked for the study. Your liver should either not be scarred (non-cirrhotic) or only mildly scarred but still working well (compensated cirrhotic).

You also need to be taking medication for Hepatitis B virus (HBV) if you have it, and have been on it for at least 12 weeks with the HBV virus under control. If you have very high liver enzyme levels, significant health problems not related to HDV that might make the study difficult for you, a history of certain serious allergic reactions, or specific immune conditions, you probably won't be able to join. Also, if you've had Bulevirtide before or are taking certain immune-affecting medicines, you would not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Have you been diagnosed with chronic HDV for at least 6 months?
Is your liver not severely scarred, or scarred but still working well?
If you have Hepatitis B, have you been on treatment for at least 3 months and is the virus controlled?
Have you *never* taken Bulevirtide before?
Do you *not* have other serious health problems, severe allergies, or certain immune conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to receive either the combination of Tobevibart and Elebsiran, or Bulevirtide. This would involve regular visits to the study clinic for check-ups, blood tests, and to receive your study medication. Doctors and nurses would closely monitor your health and how the treatment is affecting your HDV infection and liver. They will also look for any side effects. The total duration of the study, including all treatments and follow-up visits, would be explained to you in detail by the study team. You'll have all your questions answered before you make any decisions.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment option for your HDV infection, which might help control the virus and improve your liver health. However, as with any medication, there's always a chance of side effects or risks of discomfort from study procedures like blood tests. The study team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (31)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Brussels, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Sofia, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Clichy, France
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Créteil, France
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Limoges, France
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Rennes, France
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Toulouse, France
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Hanover, Germany

Common questions

What is HDV?

HDV stands for Hepatitis Delta Virus. It's a type of virus that can cause a long-lasting infection of the liver, often making Hepatitis B infection more severe.

What are Tobevibart, Elebsiran, and Bulevirtide?

These are medicines that aim to treat HDV infection. Bulevirtide is an existing treatment, while Tobevibart and Elebsiran are newer medicines being tested. This study compares them.

Will I know which treatment I'm getting?

In many studies like this, you might not know if you're getting the new combination or the existing treatment. This is called 'blinding' and helps ensure the results are fair.

What does 'Phase 2' mean?

Phase 2 means these new medicines have already passed initial safety tests and are now being studied in a larger group of people to see how effective they are and to learn more about side effects.

How long will the study last if I join?

The exact duration for each participant depends on the study plan. The research team will tell you the expected length, including treatment and follow-up visits.