Active not recruitingPHASE2INTERVENTIONAL

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

This is a study called SOLSTICE, focusing on people in the UK who have a long-term liver infection called Hepatitis D. Researchers are testing two new medicines, VIR-2218 and VIR-3434, sometimes given together, to see if they can help. It's a second-stage study (Phase 2), which means the main goals are to make sure the treatments are safe, that people can take them without too many problems, and to get an idea of how well they work against the Hepatitis D virus. Participants may start on one medicine and then switch to a combination, with careful monitoring throughout.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Vir Biotechnology, Inc.

Enrolment target

Start

17 Sep 2022

Estimated completion

01 Aug 2029

Hepatitis D, Chronic

What is this study about?

If you have Hepatitis D that's been around for a while, you might be interested in the SOLSTICE trial. This study is exploring new ways to treat this condition using specific medicines called VIR-2218 and VIR-3434. These aren't widely available yet, so this trial is an important step to understand if they could become future treatment options. It's really about advancing our knowledge to help people with Hepatitis D.

The trial is in its second phase, which means the research team is mainly focused on checking a few key things: first, that these new medicines are safe for people to take; second, that they don't cause too many uncomfortable side effects (this is called tolerability); and third, whether they show promise in fighting the Hepatitis D virus effectively. Sometimes, participants might start on one of the new medicines and then switch to taking a combination of them.

Studying new treatments like this is crucial because it helps doctors and scientists understand how to better manage chronic Hepatitis D. By taking part, you could contribute to medical science and potentially help yourself and others who are living with this condition in the future.

Key takeaways

Exploring new treatments (VIR-2218, VIR-3434) for long-term Hepatitis D.
This is a Phase 2 study, focusing on safety, tolerability, and initial effectiveness.
Participants will receive study medicines and have regular check-ups.
Strict eligibility rules ensure the study is safe for participants.
Participation involves a significant time commitment for monitoring and treatment.

Who may be eligible?

The SOLSTICE study is looking for adults aged between 18 and 69 years old who have had Hepatitis D for at least six months. You would need to have been taking a standard antiviral medicine (called NRTI) for at least 12 weeks before joining. Your liver test results (ALT) should be slightly higher than normal but not extremely high, and you should not have advanced liver scarring (cirrhosis) or only a very mild form of it.

There are also some reasons why you might not be able to join. For example, if you have other serious medical or mental health conditions, or if you've had certain severe allergic reactions in the past. People with significant liver disease from other causes not related to Hepatitis B or D, or those with certain immune system problems, would also not be able to take part. Also, if you've recently used strong immune-affecting medicines or had chemotherapy, you wouldn't be eligible.

The research team will carry out detailed checks to make sure the study is right for you and that you meet all these requirements, ensuring it's safe for you to participate.

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 69 years old?
Have you had Hepatitis D for at least 6 months?
Have you been taking an NRTI medicine for at least 12 weeks?
Do you have mild to moderate liver enzyme levels (ALT)?
Do you not have advanced liver scarring (cirrhosis) or only a very mild form?
Do you have no other serious medical conditions that could affect your participation?

Answer every question to see your result.

What does participation involve?

If you join the SOLSTICE study, you'll be given one or more of the new medicines, VIR-2218 and/or VIR-3434, to take. Initially, some people might take one medicine and then switch to a combination of them later in the study. You'll have regular visits to the clinic so the research team can carefully check your health, see how you're reacting to the medication, and monitor your Hepatitis D. These visits will involve various assessments, like blood tests, to make sure the treatment is safe and to see if it's working. The exact length of your participation and the number of visits will depend on which group you're in, but it will involve ongoing monitoring for a significant period.

Potential risks and benefits

Taking part in a clinical trial could offer potential benefits, such as access to new treatments before they are widely available and careful monitoring of your health by a medical team. However, like all medicines, these new drugs may have side effects, and their long-term effects are not yet fully known. Also, there's no guarantee the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

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

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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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Pessac, France
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Rennes, France
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Toulouse, France
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Frankfurt, Germany
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Hanover, Germany
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Tübingen, Germany
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Milan, Italy
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Pisa, Italy

Common questions

What is Hepatitis D?

Hepatitis D is a type of liver infection caused by the Hepatitis D virus (HDV). It often occurs in people who already have Hepatitis B. Over time, it can cause serious liver damage.

What does 'Phase 2' mean for a trial?

Phase 2 trials are an important stage where researchers primarily check if a new medicine is safe for people to take, how well their body handles it, and if it shows early signs of working against the illness.

What are VIR-2218 and VIR-3434?

These are names for new medicines being tested in this study. They're designed to help fight the Hepatitis D virus, but they're still in the research stage.

Will I know if I'm getting the active drugs or a placebo?

This study is testing active drugs, VIR-2218 and VIR-3434, either alone or in combination. You won't be given a placebo (a dummy treatment) in this trial.

How long does the study last?

The exact duration of your participation depends on which group you are in within the study. The detailed description mentions switches to combination therapy occurring at Week 112 or 132 for certain groups, indicating a long-term commitment.