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 1)
This important study, called B-Well 1, is looking for a new way to treat adults living with long-term (chronic) hepatitis B. Researchers are testing a medicine called bepirovirsen. The main goal is to see if taking this new medicine could help people reach a 'functional cure.' This means the hepatitis B virus would be very well controlled, and people could stop all their current hepatitis B tablets. The study will check if this new approach works and if it's safe. Participants will be treated for a period, and then doctors will watch them for 24 weeks to see if the virus remains controlled even without any hepatitis B medicines.
At a glance
What is this study about?
This study is a big step in finding better treatments for chronic hepatitis B. Right now, many people with hepatitis B take daily medicines for a long time to keep the virus under control. While these medicines are very helpful, they don't usually get rid of the virus completely.
Researchers are looking for something called a 'functional cure.' This means the hepatitis B virus would be so well controlled that someone could stop all their hepatitis B medicines and still be healthy, with the virus barely detectable or inactive. This study is testing a new medication, bepirovirsen, to see if it can achieve this goal in people who are already on treatment for hepatitis B.
The B-Well 1 study is a 'Phase 3' trial, which means it's one of the final steps before a new medicine might become widely available. Doctors are carefully checking how well bepirovirsen works and if it's safe for people with chronic hepatitis B. The hope is that this new treatment could offer a way for people to eventually stop their daily medication and improve their long-term health.
Key takeaways
- This study tests a new medicine for long-term hepatitis B.
- It aims for a 'functional cure' where medication can be stopped.
- Participants will receive either the new medicine or a placebo.
- The study involves injections, regular check-ups, and blood tests.
- It's a Phase 3 trial, meaning it's a key step towards potential new treatments.
- Your health will be closely monitored even after stopping treatment.
Who may be eligible?
This study is open to adults aged 18 and older. Both men and women can take part.
To be considered for this study, you must have long-term hepatitis B and currently be taking regular hepatitis B medication. The study team will check your medical history and do some tests to make sure that taking part is safe and suitable for you.
There will be other specific health requirements for joining the study, which the study team will discuss with you. These are in place to ensure your safety and that the study results are as clear as possible.
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.
- Am I 18 years old or older?
- Do I have a diagnosis of long-term (chronic) hepatitis B?
- Am I currently on regular medication for my hepatitis B?
- Am I comfortable with injections and regular clinic visits?
What does participation involve?
If you join this study, it will involve several visits to a clinic over a period of time. You will be given either the new medicine (bepirovirsen) or a placebo (a dummy injection that looks like the medicine but contains no active drug). You have an equal chance of receiving either, and neither you nor your study doctor will know which one you are getting. Both are given as injections.
You will continue your usual hepatitis B tablets during a part of the study. After a certain period, you will stop all hepatitis B medications (bepirovirsen/placebo and your usual tablets), and the study team will closely monitor your health and the hepatitis B virus for 24 weeks. This follow-up period is crucial to see if your body can keep the virus under control without medication. Throughout the study, you will have regular check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. The total study duration will vary but typically lasts many months, including the treatment and follow-up phases.
Potential risks and benefits
Locations (9)
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- —UnverifiedFrance
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- —UnverifiedItaly
- —UnverifiedGermany
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- —UnverifiedGreece
Common questions
What is 'chronic hepatitis B'?
Chronic hepatitis B means you've had the hepatitis B virus in your body for a long time, usually more than six months. It can cause ongoing liver problems.
What is a 'functional cure' in this study?
A functional cure means the hepatitis B virus would be so well controlled that you could stop all your hepatitis B medicines and stay healthy.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers understand if the new medicine is truly effective.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know. This is called 'double-blind' and helps ensure the study results are unbiased.
Can I stop my current hepatitis B medicine if I join?
You will continue your current medicine for a period. Later in the study, if suitable, your doctor might guide you to stop all hepatitis B medicines, including the study drug, to see how your body manages.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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