Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase 2, single-blinded, randomised, controlled multi-country study to evaluate the safety, reactogenicity, efficacy and immune response following sequential treatment with an anti-sense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA) therapy.

This study is for people in different countries who have long-lasting Hepatitis B and are already taking medication for it. The main goal is to test a new combination treatment to see how safe it is and if it works well. This new treatment involves giving a special medicine first, followed by another medicine that helps boost the body's fighting power against the virus. Researchers will carefully check for any side effects and measure if the amount of Hepatitis B virus in the body goes down after treatment. The study is in an early stage (Phase 2), meaning it's one of the first times this treatment is being studied in a larger group of people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

Start

08 May 2024

Hepatitis B Chronic

What is this study about?

This study is looking into a new way to treat chronic hepatitis B, a long-term liver infection. Current treatments often help control the virus, but don't always clear it completely. This new approach involves two steps. First, participants will receive a new investigational medicine designed to reduce the amount of the virus. After that, they will receive a second investigational medicine, which is a type of immunotherapy. This kind of treatment aims to help your body's immune system get better at fighting off the hepatitis B virus itself. All participants will already be taking standard hepatitis B medication throughout the study.

The main reasons for doing this study are to understand how safe these new treatments are and to see if they can effectively lower or even clear the hepatitis B virus from the body. Researchers will be closely monitoring participants for any health changes or side effects. They will also take regular blood tests to see if the levels of the virus (and certain viral proteins) are decreasing, which would suggest the treatment is working.

By taking part, you would be helping doctors learn more about potential new ways to treat chronic hepatitis B. This could lead to better treatments for many people in the future. Remember, it's important to discuss any medical decision with your doctor to understand if a study like this might be suitable for you.

Key takeaways

This study is testing new treatments for long-term Hepatitis B.
Participants must be adults already taking Hepatitis B medication.
The new treatment involves two different injections.
The main goals are to check safety and how well the treatment reduces the virus.
Regular clinic visits and blood tests will be part of taking part.
You would contribute to finding new ways to treat Hepatitis B.

Who may be eligible?

To join this study, people need to be adults, aged 18 or older. Both men and women can participate. A key requirement is that you must have long-lasting Hepatitis B infection and already be taking a specific type of medication for it, called nucleos(t)ide analogue (NA) therapy.

There will be other health checks to make sure you are suitable for the study and that it's safe for you to take part. For example, doctors will need to review your overall health, your liver function, and your history with Hepatitis B carefully.

The research team will provide a full list of who can and cannot join. It's important to understand these details completely before deciding whether to take part.

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 diagnosis of chronic (long-lasting) Hepatitis B?
Are you currently taking a regular medication for Hepatitis B (like NA therapy)?
Are you able to attend regular clinic visits for the study?
Do you understand that this is an investigational treatment?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the new study treatments, which include two different types of injections. The study would involve a series of visits to the clinic over a period of time. During these visits, you would have regular health checks, including physical examinations, blood tests, and possibly other tests to monitor your health and the levels of the hepatitis B virus in your body. Researchers will be looking for any side effects and tracking how well the treatment is working. Your doctors will explain the exact schedule of visits and treatments, and how long your participation would last, ensuring you understand everything before you start. You would also continue to take your current hepatitis B medication throughout the study.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. Potential benefits of this study include receiving new, investigational treatments for Hepatitis B that might be more effective than current options, and contributing to medical knowledge. However, as these are new treatments, there is a risk of side effects, which could range from mild discomfort at the injection site to more serious reactions. The study team will carefully monitor your health throughout. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

—
Unverified
Belgium
—
Unverified
Italy
—
Unverified
Germany
—
Unverified
Romania
—
Unverified
France
—
Unverified
Spain
—
Unverified
Bulgaria
—
Unverified
Poland

Common questions

What is chronic Hepatitis B?

Chronic Hepatitis B is a long-lasting infection of the liver caused by the Hepatitis B virus. It can lead to serious liver problems over time if not managed.

What kind of treatment will I receive in this study?

You will receive two new experimental medicines, given as injections, in addition to your current Hepatitis B medication. One aims to reduce the virus, and the other aims to boost your immune system against it.

Will I have to stop my current Hepatitis B medication?

No, you will continue taking your current Hepatitis B medication (like nucleos(t)ide analogue therapy) throughout the study.

What does a 'Phase 2' study mean?

A Phase 2 study means these new treatments are being tested in a larger group of people for the first time, to see if they are safe and if they seem to work before moving to even larger studies.

What will happen if I join the study?

If you join, you will have regular clinic visits for health checks, blood tests, and to receive the study medications. The medical team will closely monitor you for any side effects and how your body responds to the treatment.