Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants with Chronic Hepatitis B Infection (PREVAIL)

The PREVAIL study is a research project looking into new treatments for people who have had Hepatitis B for a long time. It's investigating how well some experimental drugs work, both on their own and with existing medications, to control the virus. Researchers want to see if these new treatments can significantly lower the amount of Hepatitis B virus in the body and make a key marker of the infection, called HBsAg, disappear. They will also be carefully monitoring for any side effects to make sure the treatments are safe. This is a Phase 2 study, meaning it's exploring how effective the treatments are.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vir Biotechnology Inc.

Enrolment target

Start

15 Oct 2024

Chronic Hepatitis B Virus (HBV) Infection

What is this study about?

This research study, known as PREVAIL, is focused on finding better ways to treat chronic Hepatitis B. Chronic Hepatitis B is a long-term infection that can lead to serious liver problems if not managed. While current treatments can help control the virus, they don't always fully clear the infection. This study is testing some brand-new medicines that doctors hope could offer a more effective solution.

The main goal of PREVAIL is to see if these new treatments can dramatically reduce the amount of Hepatitis B virus in a person's body and, importantly, make a specific marker of the infection called HBsAg disappear completely. Losing HBsAg is a sign that the body might be clearing the virus, which is a big step towards a potential cure. The study will look at how well this happens after people stop taking the treatment.

The research will also carefully monitor the participants for any side effects of the new medicines. This is crucial for understanding whether these treatments are not only effective but also safe for people to use. By studying these new drugs in combination with existing ones, researchers hope to improve how we manage and potentially overcome chronic Hepatitis B.

Key takeaways

Tests new medicines for long-term Hepatitis B.
Aims to reduce the virus and remove a key infection marker (HBsAg).
Also checks for safety and side effects.
Participation involves regular clinic visits and tests.
Could offer access to new potential treatments.
You can leave the study at any time.

Who may be eligible?

To join the PREVAIL study, you must be 18 years old or older. The study is open to both men and women.

There will be other health requirements and tests you need to pass to make sure the study is a good fit for you and that the results will be accurate. For example, doctors will need to confirm you have chronic Hepatitis B and that your liver is functioning well enough to safely participate.

It's very important to discuss your full medical history with the study doctors to see if you meet all the criteria.

Quick self-check

Are you 18 years old or older?
Do you have chronic (long-term) Hepatitis B?
Are you able to attend regular clinic appointments?
Are you willing to follow a specific treatment plan?
Have you discussed your participation with your doctor?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the PREVAIL study, you will be given a specific treatment plan that involves taking either new experimental medicines, existing Hepatitis B medication, or a combination of both. These could be injections or tablets. You will have regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. These visits will help doctors track your virus levels, check for any side effects, and generally ensure your well-being. The total duration of your participation, including follow-up after stopping treatment, will be explained by the study team, but it will involve ongoing assessments for at least 24 weeks after your treatment ends.

Potential risks and benefits

Participating in a clinical trial like PREVAIL could offer you access to new treatments for chronic Hepatitis B that are not yet widely available. There's a chance these new medicines could work better for you than existing options, potentially offering a more complete response to your infection. However, like all medicines, the experimental drugs in this study may have side effects, some of which might be unknown or serious. There's also no guarantee that 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 (2)

—
France
—
Romania

Common questions

What is chronic Hepatitis B?

Chronic Hepatitis B is a long-term infection of the liver caused by the Hepatitis B virus. It can lead to serious health problems over time.

What is HBsAg?

HBsAg is a specific marker or 'flag' of the Hepatitis B virus found in your blood. If it disappears, it's a good sign that your body is overcoming the infection.

What does 'experimental therapies' mean?

It means the medicines being tested are new and are still being studied to see if they are safe and effective for treating Hepatitis B.

Will I know which treatment I'm getting?

In some studies, you might be assigned to a treatment group randomly, and sometimes neither you nor your doctor will know which specific treatment you are receiving until after the study ends. This helps ensure fair and accurate results.

What happens after the treatment period ends?

Even after you stop taking the study medicines, you will have follow-up visits and tests for several months to see if the positive effects of the treatment continue and to monitor your long-term health.