Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate the safety and tolerability of dostarlimab in adult participants with chronic HBV infection on nucleos(t)ide analogue (NA) treatment

This research study is about a new medicine called dostarlimab. It's being tested in adults who have a long-term (chronic) hepatitis B infection. These individuals are already taking standard medicines, known as nucleos(t)ide analogues, for their condition. The main purpose of this study is to carefully check if dostarlimab is safe to use and how well people tolerate it – meaning, how comfortably they can take it and if they experience any side effects. This is a very early stage of testing for this specific use, often called 'Phase I', where the focus is firmly on safety rather than whether the medicine cures the condition. All adults are welcome to be considered for participation.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

11 Nov 2024

Hepatitis B Chronic

What is this study about?

This study is investigating a new medicine called dostarlimab for people who have a long-term viral infection of the liver, known as chronic hepatitis B. Hepatitis B can cause serious health problems over time, so finding effective treatments is very important.

Currently, many people with chronic hepatitis B take medicines called nucleos(t)ide analogues. These medicines help to control the virus, but they don't always clear the infection completely. Researchers are always looking for new ways to improve treatment and potentially offer better outcomes for patients.

This particular study is a very early stage (Phase I) of testing. This means the main goal is to understand how safe dostarlimab is when given to people who already have hepatitis B and are on existing treatment. Researchers also want to see how well people tolerate the new medicine. At this stage, they are not primarily looking at whether the medicine cures the disease, but rather making sure it's safe enough to study further.

Key takeaways

This study is testing a new medicine (dostarlimab) for chronic hepatitis B.
It's an early-stage study primarily focused on checking the medicine's safety.
Participants must be adults already on standard hepatitis B treatment.
You will continue your current hepatitis B medication if you join.
All participants will be closely monitored for any side effects.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also be included.

You must have a long-term (chronic) hepatitis B infection. This means you've had the infection for a while, not just recently caught it.

You also need to be currently taking medicines for your hepatitis B. These are typically drugs like entecavir or tenofovir, often called 'nucleos(t)ide analogues.' 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 18 years old or older?
Do you have a long-term (chronic) hepatitis B infection?
Are you currently taking medication for your hepatitis B (like entecavir or tenofovir)?
Are you comfortable with regular clinic visits and health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, dostarlimab, in addition to your current hepatitis B treatment. You would have regular visits to the study clinic to check your health, take blood samples, and make sure you're tolerating the new medicine well. These visits might involve physical examinations and other tests. The study team will explain how often these visits would be and what happens at each one. Your progress would be closely monitored throughout the study and for a period afterwards to track any effects of the medicine. The total duration of your participation, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit could be access to a new treatment option that might help control your hepatitis B, although the primary goal of this early-stage study is to assess safety, not effectiveness. Potential risks might include side effects from the new medicine, which the study team will monitor very closely. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

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

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Unverified
Bulgaria
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Unverified
France
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Unverified
Italy
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Unverified
Spain

Common questions

What is 'chronic hepatitis B'?

It's a long-term infection of the liver caused by the hepatitis B virus. It can cause serious liver problems over many years.

What are 'nucleos(t)ide analogue' treatments?

These are common antiviral medicines, like entecavir or tenofovir, that are used to help control the hepatitis B virus in your body.

What does 'Phase I study' mean?

This is an early stage of research where doctors mainly focus on checking if a new medicine is safe for people and how well they tolerate it, rather than if it cures the disease.

Will I stop my current hepatitis B medication?

No, participants in this study will continue to take their current hepatitis B medication while also receiving the new study medicine, dostarlimab.

Will this new medicine cure my hepatitis B?

While researchers hope to find better treatments, the main aim of this early study is to check the medicine's safety and how well people tolerate it, not whether it cures hepatitis B. That would be looked at in later studies.