Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
This research study is for people who have chronic Hepatitis D, which is a long-term liver infection. It's called a 'Phase 2b/3' study, meaning it's a later stage of research aiming to combine evidence from earlier stages. The main goal is to find out if switching from a current treatment called Bulevirtide to a new medicine called Brelovitug is safe and effective. Participants will be randomly assigned to continue Bulevirtide or switch to Brelovitug, and the study will compare their effects. This investigation is important for potentially finding better ways to manage chronic Hepatitis D and improve people's health.
At a glance
What is this study about?
This study is about people who have a long-term liver infection called chronic Hepatitis D. If you have this condition, your doctor might have given you a medicine called Bulevirtide. This study wants to find out if there's a potentially better option available.
Researchers are looking at a new medicine called Brelovitug (you might also see it called BJT-778). The main idea is to see what happens when people who are already taking Bulevirtide switch to Brelovitug. Doctors will be checking to see if this new medicine is safe to use and if it works well to control the Hepatitis D infection. This is called a 'Phase 2b/3' study, which means it's a more advanced stage of research, building on what was learned in earlier studies.
Understanding if new medicines like Brelovitug can offer more benefits or fewer side effects than current treatments is very important. Studies like this help doctors find the best ways to help people with conditions like chronic Hepatitis D.
Key takeaways
- Tests a new medicine (Brelovitug) for chronic Hepatitis D.
- Compares switching from current medicine (Bulevirtide) to the new one.
- Aims to check safety and how well the new medicine works.
- For adults (18+) already on Bulevirtide.
- Careful health checks and follow-up during the study.
Who may be eligible?
To join this study, you must be at least 18 years old and willing to give your written consent to participate. You should also be taking other hepatitis medicines like TDF, TAF, or ETV at the start of the study and plan to continue them throughout.
A key requirement is that you must have been taking Bulevirtide for your chronic Hepatitis D for at least six months before the study begins. You also need to have a certain level of the Hepatitis D virus in your blood when checked at the start.
There are also reasons why you might not be able to join. For example, if you have severe liver damage, or other serious liver conditions, or other infections like Hepatitis C or HIV, you wouldn't be able to take part. Also, if you have a history of certain immune problems or liver cancer, this study wouldn't be suitable for you.
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?
- Are you currently taking Bulevirtide for chronic Hepatitis D for at least 6 months?
- Are you also taking TDF, TAF, or ETV and can continue taking it?
- Do you currently have a detectable level of Hepatitis D virus in your blood?
- Do you NOT have severe liver damage or other serious liver conditions?
- Do you NOT have other infections like Hepatitis C or HIV?
What does participation involve?
If you decide to take part in this study, you'll first have some checks to make sure you're suitable. Once you're in, you'll be randomly assigned to either stay on Bulevirtide or switch to the new medicine, Brelovitug. You'll take the study medication regularly as prescribed. You'll need to attend clinic visits for health checks, blood tests, and to make sure everything is going well. These visits will help doctors monitor your health and how the medicine is working. The study will last for a certain period, which your doctor will explain, and during that time, you'll have regular follow-up appointments.
Potential risks and benefits
Locations (22)
- Medical University of GrazVerified postcodeGraz, Austria· Recruiting
- Fakultni Nemocnice Brno (University Hospital Brno)Verified postcodeBrno, Czechia· Recruiting
- Klin Med Ltd. (KLIN MED s.r.o.)Verified postcodePrague, Czechia· Recruiting
- Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)Verified postcodePrague, Czechia· Recruiting
- CHU de BordeauxVerified postcodeBordeaux, France· Recruiting
- Hospital BeaujonVerified postcodeClichy, France· Recruiting
- CHU Toulouse Hospital Rangueil, ToulouseVerified postcodeToulouse, France· Recruiting
- University Hospital of DusseldorfVerified postcodeDüsseldorf, Germany· Recruiting
- Goethe University FrankfurtVerified postcodeFrankfurt, Germany· Recruiting
- Medizinische Hochschule HannoverVerified postcodeHanover, Germany· Recruiting
- Universitatsmedizin RostockVerified postcodeRostock, Germany· Recruiting
- Centrul Medical Unirea S.R.LVerified postcodeIași, Romania· Recruiting
Common questions
What is chronic Hepatitis D?
It's a long-term infection that affects the liver, and it only happens in people who already have Hepatitis B.
What is Bulevirtide?
It's a medicine currently used to treat chronic Hepatitis D.
What is Brelovitug (BJT-778)?
It's a new medicine being tested to see if it can be an effective treatment for chronic Hepatitis D.
Will I know if I'm getting the new medicine or staying on my old one?
Yes, this is an 'open-label' study, which means both you and your study doctor will know which medicine you are taking.
Can I leave the study at any time?
Yes, you are free to leave the study at any point without it affecting your usual medical care.
How to find out more
Clinical Trials Mirum
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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