A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
This study is looking into new ways to treat chronic Hepatitis B, a long-term liver infection. It specifically investigates two new medications, daplusiran/tomligisiran (DAP/TOM) and bepirovirsen, in people who are already taking standard Hepatitis B medicines. The main goals are to see how well these new drugs work and if they are safe when used one after the other. Researchers also want to figure out the best dose of DAP/TOM to combine with bepirovirsen for future treatments. Your current Hepatitis B medication will continue as usual during the initial phase, and the study will assess the new medicines' impact.
At a glance
What is this study about?
This research study is about finding better treatments for chronic Hepatitis B. This is a long-term infection caused by the Hepatitis B virus, which can affect your liver over many years. Currently, many people with chronic Hepatitis B take medicines called nucleos(t)ide analogues (NAs) to control the virus. This study is exploring if adding new medications can make treatments even more effective.
The new medications being tested are called daplusiran/tomligisiran (DAP/TOM) and bepirovirsen. The study will involve giving participants DAP/TOM first, followed by bepirovirsen. Researchers want to understand how well this combination works to reduce the amount of virus in the body and if it is safe. They will be comparing two different doses of DAP/TOM to see which one is most effective when used before bepirovirsen.
Ultimately, the aim is to find an improved treatment plan that could help people living with chronic Hepatitis B achieve better health outcomes. By learning more about these new drugs and how to best use them together, doctors hope to develop new standard treatments in the future.
Key takeaways
- This study evaluates new drugs for chronic Hepatitis B in people already on standard treatment.
- It tests two doses of DAP/TOM followed by bepirovirsen to find the best combination.
- Participation involves taking new medications, regular clinic visits, and blood tests.
- You must be 18+ with stable long-term Hepatitis B and currently on specific medication.
- Potential benefits include access to new treatments; potential risks include side effects.
- You can stop participating at any time without affecting your normal medical care.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a confirmed long-term Hepatitis B infection for at least six months. You must also be taking your current Hepatitis B medication (like tenofovir or entecavir) regularly and stably for at least six months, with no plans to change it during the study. Your current medication should be successfully controlling the virus to a very low level in your blood.
There are also some things that would mean you can't join. For example, if you have other serious health problems, such as moderate to severe other liver diseases, recent heart problems, uncontrolled diabetes, or certain other infections (like Hepatitis C, HIV, or Hepatitis D). You also can't have a history or suspicion of liver scarring (cirrhosis) or liver cancer.
It's important that you would be willing and able to stop your current Hepatitis B medication later in the study if the doctors think it's appropriate for your care within the study's plan. Both men and women are welcome 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 at least 18 years old?
- Have you had chronic Hepatitis B for at least 6 months?
- Are you currently taking regular Hepatitis B medication and have been for at least 6 months?
- Is your Hepatitis B virus well-controlled by your current medication (very low levels in your blood)?
- Have you not had any severe liver problems (scarring or cancer) or other major health issues recently?
- Are you willing to potentially stop your current Hepatitis B medication later, if the study requires it?
What does participation involve?
If you decide to take part, you will continue your current Hepatitis B medication as usual in the beginning. The study involves taking two different new medications, DAP/TOM and then bepirovirsen, over a period of time. You will be assigned to receive one of two different doses of DAP/TOM. You might also receive a placebo, which looks like the active drug but contains no medicine, to help researchers understand the true effect of the study drugs.
Throughout the study, you'll have regular visits to the clinic for medical check-ups, blood tests, and perhaps other assessments. These tests help doctors monitor your health, how the medicines are working, and check for any side effects. The total duration of your involvement in the study will be agreed upon with the study team, and it involves a follow-up period after you stop taking the study medications.
Potential risks and benefits
Locations (81)
- GSK Investigational SiteVerified postcodeSan Francisco, United States
- GSK Investigational SiteVerified postcodeSan Jose, United States
- GSK Investigational SiteVerified postcodeMinneapolis, United States
- GSK Investigational SiteVerified postcodeNew York, United States
- GSK Investigational SiteVerified postcodePhiladelphia, United States
- GSK Investigational SiteVerified postcodeWestmead, Australia
- GSK Investigational SiteVerified postcodeFitzroy, Australia
- GSK Investigational SiteVerified postcodeBrussels, Belgium
- GSK Investigational SiteVerified postcodeEdegem, Belgium
- GSK Investigational SiteVerified postcodeGhent, Belgium
- GSK Investigational SiteVerified postcodeAracaju, Brazil
- GSK Investigational SiteVerified postcodeCuritiba, Brazil
Common questions
What is chronic Hepatitis B?
It's a long-term infection of the liver caused by the Hepatitis B virus, which can lead to serious liver problems over time.
What are DAP/TOM and bepirovirsen?
These are new experimental medicines being tested in this study to see if they can better treat Hepatitis B.
Will I stop my current Hepatitis B medication?
You will continue your current medication initially, but later in the study, you might be asked to stop it temporarily under close medical supervision as part of the study plan.
What is a placebo?
A placebo is a substance that looks like the study drug but has no active medicine. It helps researchers understand if the real drug is effective.
How long will the study last?
The full duration of your participation, including follow-up, will be discussed with you by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.