RecruitingPHASE2INTERVENTIONAL

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

This is a follow-up study for people who previously participated in a trial for a Hepatitis B treatment called bepirovirsen. The main goal is to see if the improvements they experienced during the original study continue in the long term. Participants must have shown a good response to bepirovirsen in their previous study. This isn't a new treatment study; it's about checking if the earlier treatment's effects are lasting. Patients will be grouped based on whether they were taking other Hepatitis B medications (like NAs) during their first study. No new bepirovirsen will be given. This research helps us understand the lasting impact of the treatment on Hepatitis B.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

450

Start

14 Dec 2021

Estimated completion

08 Feb 2029

Hepatitis B

What is this study about?

This study, called B-Sure, is a very important follow-up for people who have taken part in previous trials researching a new Hepatitis B treatment called bepirovirsen. Imagine you've taken a course of treatment and felt much better – this study wants to see if those positive effects stick around for a long time after the treatment has finished. It's designed to track how well participants are doing and if their improvements in Hepatitis B markers remain stable without needing more bepirovirsen.

The main aim is to understand the long-term impact and 'durability' of bepirovirsen. This means researchers are looking to see if the levels of the Hepatitis B virus remain low, and if key markers in the blood continue to show improvement, months or even years after the original study ended. By carefully monitoring these participants, scientists hope to learn more about how bepirovirsen works and its potential to provide lasting benefits against Hepatitis B.

It’s crucial to understand that no new bepirovirsen treatment will be given in this study. It's purely observational, meaning researchers will be collecting information and monitoring participants' health and Hepatitis B status. This will give them valuable insights into how enduring the effects of bepirovirsen are, which is vital for developing better treatments for Hepatitis B in the future.

Key takeaways

This is a follow-up study, not a new treatment trial.
It aims to see if bepirovirsen's benefits for Hepatitis B last over time.
Only participants from specific previous bepirovirsen trials can join.
You must have shown a good response to treatment in your first study.
You will be monitored, and blood tests will be taken regularly.

Who may be eligible?

To be able to join this study, you must have previously taken part in one of the specific bepirovirsen studies mentioned (like B-Clear, B-Together, or B-Well, among others). A key requirement is that you gave your permission to take part in research and that you showed a good response to bepirovirsen in your original study. This means your Hepatitis B virus levels (HBsAg and HBV DNA) must have reached certain improved levels and stayed there until the end of your first study.

Specifically, for those who were on other Hepatitis B medicines called NAs (nucleos(t)ide analogues) during their previous study, you must be willing and able to stop taking these NA treatments following a planned schedule when you join this study. This is so researchers can see how your body manages without the combined treatments.

Ultimately, this study is looking for people who responded well to bepirovirsen previously, maintained those good results, and are now willing to be monitored long-term to see if those benefits continue.

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.

Did I participate in a previous bepirovirsen study?
Did I show a good response to bepirovirsen in that study (e.g., low virus levels)?
Am I willing to have regular health check-ups and blood tests?
If I was on other Hepatitis B medications (NAs), am I willing to discuss stopping them under medical guidance?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will not receive any new bepirovirsen treatment. Instead, your participation will involve regular check-ups and monitoring to see how your body is doing in the long term after your previous bepirovirsen study. This will include blood tests to check your Hepatitis B virus levels and other general health markers. You will be grouped based on whether you were taking other Hepatitis B medications (NA treatment) during your previous study. If you were on NA treatment, you would be guided on stopping this medication as part of the study. The total duration of your participation will depend on the specific original study you were in, but it is designed as a long-term follow-up to observe sustained effects.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of how bepirovirsen works in the long term, which could help future patients with Hepatitis B. For participants who were on other Hepatitis B medications (NAs) in their previous study, there might be a benefit from attempting to stop these medications under medical supervision, if suitable. As no new experimental drug is given in this follow-up, the risks are generally low, mainly related to blood draws and the potential for a return of Hepatitis B virus activity if NA treatment is stopped. You would be closely monitored, and you are free to withdraw from the study at any time without giving a reason, and this would not affect your regular medical care.

Locations (51)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
Verified postcode
Sacramento, United States· Recruiting
GSK Investigational Site
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Boston, United States· Recruiting
GSK Investigational Site
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Detroit, United States· Recruiting
GSK Investigational Site
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Buenos Aires, Argentina· Recruiting
GSK Investigational Site
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Sliven, Bulgaria· Recruiting
GSK Investigational Site
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Sofia, Bulgaria· Recruiting
GSK Investigational Site
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Calgary, Canada· Recruiting
GSK Investigational Site
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Victoria, Canada· Recruiting
GSK Investigational Site
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Toronto, Canada· Recruiting
GSK Investigational Site
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Hangzhou, China· Recruiting
GSK Investigational Site
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Shanghai, China· Recruiting
GSK Investigational Site
Verified postcode
Wuhan, China· Recruiting

Common questions

What is bepirovirsen?

Bepirovirsen is a new treatment for Hepatitis B that has been tested in previous clinical trials.

Will I get more bepirovirsen treatment in this study?

No, this study is a follow-up, so no new bepirovirsen medication will be given.

Why is this study important?

It helps us understand if the positive effects of bepirovirsen treatment last for a long time after the original trial ends.

What does 'NA-cessated' mean?

It refers to participants who have successfully stopped taking other Hepatitis B medications called nucleos(t)ide analogues (NAs).

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.