Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 2)
This clinical trial is for people who have chronic (long-term) Hepatitis B and are already taking medication for it. The study is testing a new medicine called Bepirovirsen. The main goal is to see if participants can achieve a 'functional cure' – meaning their Hepatitis B is well controlled for at least 24 weeks after stopping all their usual and study medicines. This would be a significant step forward, as it could mean some people might no longer need daily Hepatitis B treatment. Researchers will compare Bepirovirsen to a dummy treatment (placebo) to understand how effective and safe it is. It's a large study involving many different centres, helping us learn more about potential new ways to manage Hepatitis B.
At a glance
What is this study about?
This study, called B-Well 2, is looking for a new and better way to treat chronic Hepatitis B, a long-lasting liver infection. Many people with Hepatitis B need to take medication every day for a very long time. The researchers want to find out if a new medicine, Bepirovirsen, can help people get to a point where they can stop all their Hepatitis B medicines and still keep the virus under control.
Imagine taking medicine for years, and then being able to stop and feel well. That's the hope of this study. They are aiming for what's called a 'functional cure.' This isn't the same as completely getting rid of the virus, but it means the virus is controlled so well that it doesn't cause harm, and you don't need regular treatment.
To see if Bepirovirsen works, some people in the study will get the new medicine, and others will get a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This helps researchers fairly compare the new treatment. By the end, they hope to understand if Bepirovirsen is effective and safe for people with chronic Hepatitis B.
Key takeaways
- Tests a new medicine (Bepirovirsen) for long-term Hepatitis B.
- Aims for a 'functional cure' where daily medicines might not be needed.
- Compares Bepirovirsen to a dummy treatment (placebo).
- For adults aged 18 and over who already take Hepatitis B medication.
- Involves regular clinic visits and close health monitoring.
- Could help find new, better ways to manage Hepatitis B.
Who may be eligible?
This study is looking for adult volunteers, aged 18 or older, who have been diagnosed with chronic Hepatitis B. Both men and women are welcome to take part.
You will likely need to be already taking certain medications for your Hepatitis B (called nucleos(t)ide analogues) before you can join the study. The medical team will check other health details to make sure the study is a good fit for you and safe for your health.
It's important to remember that even if you meet these general criteria, there might be other specific health factors or current medications that could mean you're not able to join. The study doctors will carefully review everything during a screening process.
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 18 years old or older?
- Do you have a diagnosis of chronic (long-term) Hepatitis B?
- Are you currently taking medication for your Hepatitis B (like nucleos(t)ide analogues)?
- Are you able to attend regular clinic appointments?
What does participation involve?
Taking part in this study would involve regular visits to the clinic over a period of time. You would continue taking your current Hepatitis B medication, and at certain points, you would also receive either the study drug, Bepirovirsen, or a placebo, given as an injection.
Throughout the study, the medical team will monitor your health closely through blood tests, physical examinations, and possibly other tests to see how you are responding to treatment and to check for any side effects. After a period of taking the study medication, you might be asked to stop all your Hepatitis B treatments, and the team will continue to follow your health for at least 24 weeks after that to see how your body manages the virus without medication. The total duration of your participation, including the treatment and follow-up phases, will be explained in detail by the study team.
Potential risks and benefits
Locations (9)
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedGreece
- —UnverifiedBulgaria
Common questions
What is 'functional cure' in this study?
A 'functional cure' means your body controls the Hepatitis B virus so well that you might not need to take daily medication anymore, even though the virus might still be present at very low levels.
Will I definitely receive the new medicine?
No, because it's a 'randomized' study, you might receive the new medicine (Bepirovirsen) or a dummy treatment (placebo). This helps researchers fairly compare them.
What is a 'placebo'?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps compare the real medicine's effects accurately.
How long will I be in the study?
The study involves a treatment period and a follow-up period after stopping medicines. The exact length will be explained by the study team, but can be several months to a year or more.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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