RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide

This research study is looking for people with long-term Hepatitis D (HDV) infection. Specifically, it's for those whose current treatment with bulevirtide isn't fully clearing the virus from their body. The aim is to see if a new combination of two other medicines, called tobevibart and elebsiran, can be more effective. This study is in its final stages of testing, called Phase 3, and involves several medical centres. Participants will be randomly assigned to different treatment groups to compare how well the new combination works. The goal is to find better ways to manage chronic HDV infection, which can cause serious liver problems, and improve health outcomes for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Vir Biotechnology, Inc.

Enrolment target

150

Start

30 Jul 2025

Estimated completion

01 Jul 2031

Viral Hepatitis

What is this study about?

This study is looking into new ways to treat chronic Hepatitis D (HDV) infection. HDV is a liver disease caused by a virus that only affects people who also have Hepatitis B (HBV). Over time, chronic HDV can lead to serious liver damage, including scarring (cirrhosis) and liver failure. Currently, one of the treatments available is a drug called bulevirtide.

However, for some people, bulevirtide might not fully get rid of the HDV virus from their bodies. This study wants to see if a different approach, using a combination of two new medicines – tobevibart and elebsiran – could be more effective. By testing these new drugs together, researchers hope to find a better treatment option for those who aren't fully responding to their current medicine.

Finding more effective treatments for chronic HDV is really important because it can improve people's long-term health and reduce the risk of severe liver problems. This research is a crucial step towards giving patients more choices and better outcomes in managing this challenging condition.

Key takeaways

Tests new combination therapy (tobevibart + elebsiran) for chronic Hepatitis D.
For those whose current bulevirtide treatment isn't fully suppressing the virus.
Phase 3 study, meaning it's a key step towards potential approval.
Aims to find more effective treatments for HDV to prevent liver complications.
Requires participants to be between 18 and 70 years old with stable liver health.

Who may be eligible?

This study is looking for adults aged between 18 and 70 years old. To be considered, you must have chronic Hepatitis D (HDV) infection, with a certain level of the virus still detectable in your blood even though you've been taking bulevirtide for at least six months. Your liver condition should be stable, meaning you either don't have cirrhosis, or if you do, it's not severe. You also need to be taking medicine for Hepatitis B (HBV) if your HBV virus levels are detectable, or have very low HBV levels.

You would not be able to join the study if your liver enzymes are very high, or if you have any other significant health conditions that the study doctors feel would make it unsafe for you to participate. This also includes any serious liver disease not caused by HBV or HDV.

You also can't participate if you've had allergic reactions to similar medicines in the past, or if you're currently taking certain medications that affect your immune system, such as steroids or chemotherapy, or have taken them in the last six months. A history of certain immune problems, like autoimmune disorders or anaphylaxis, would also prevent you from joining.

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?
Do you have chronic Hepatitis D (HDV) and are currently taking bulevirtide?
Is the HDV virus still detectable in your blood despite taking bulevirtide for at least 6 months?
Do you have stable liver health (no severe cirrhosis)?
Are you able to take the study medicines and attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you're a good fit. If eligible, you will be randomly assigned to one of the study groups. This means you might receive the new combination of tobevibart and elebsiran, or you might continue with your current treatment with bulevirtide, depending on what the study needs to compare.

You will have regular visits to the clinic for check-ups, blood tests, and to receive your study medication. These visits will help doctors monitor your health and how the treatment is working. The exact number and frequency of visits will be explained by the study team, as will the total duration you are expected to be in the study, including any follow-up appointments after you stop taking the study medication. All medications and specific procedures related to the study will be provided as part of your participation.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if the new combination of medicines is more effective at controlling your Hepatitis D than your current treatment. You would also receive close medical attention and monitoring throughout the study. However, like all medicines, the new treatments could have side effects, and some are still unknown as they are being newly tested. There is also no guarantee that the new treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (38)

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

Investigative Site
Verified postcode
Innsbruck, Austria· Recruiting
Investigative Site
Verified postcode
Vienna, Austria· Recruiting
Investigative Site
Verified postcode
Bobigny, France· Recruiting
Investigative Site
Verified postcode
Clichy, France· Recruiting
Investigative Site
Verified postcode
Créteil, France· Recruiting
Investigative Site
Verified postcode
Le Chesnay, France· Recruiting
Investigative Site
Verified postcode
Limoges, France· Recruiting
Investigative Site
Verified postcode
Lyon, France· Recruiting
Investigative Site
Verified postcode
Montpellier, France· Recruiting
Investigative Site
Verified postcode
Pessac, France· Recruiting
Investigative Site
Verified postcode
Rennes, France· Recruiting
Investigative Site
Verified postcode
Toulouse, France· Recruiting

Common questions

What is Hepatitis D (HDV)?

Hepatitis D is a liver infection caused by a virus. It only affects people who already have Hepatitis B. It can lead to serious liver damage.

What does 'not virologically suppressed' mean?

It means that your current medicine is not fully controlling or clearing the Hepatitis D virus from your body, and the virus is still detectable at a certain level.

What are Phase 3 studies?

Phase 3 is typically the final stage of testing a new medicine before it can be approved. It involves many people and aims to confirm how well it works and if it's safe.

Will I know which treatment I'm getting?

Because this is an 'open label' study, you and your doctors will know which treatment you are receiving (either the new combination or continuing bulevirtide).

Will I have to pay for the study medicines?

No, all study-related medications and visits will be provided at no cost to you.

How to find out more

Study Injury

clinicaltrials@vir.bio 415-654-5281 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.