Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination with Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects with Chronic HBV Infection

This study is for people living with long-term Hepatitis B. It's looking at a new treatment called Imdusiran, given together with Durvalumab (known as Imfinzi), which is a medicine already used in some conditions. The main goal is to find out how safe this combination is and if people can take it without too many problems. Researchers will also observe how the medicine works in the body. This is an early-stage study, meaning it's a step towards understanding if this new approach could eventually help people with Hepatitis B. It’s important for finding better ways to manage this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Arbutus Biopharma Inc.

Enrolment target

Start

10 Jun 2024

Chronic HBV Infection

What is this study about?

This study is all about finding new and better ways to treat Hepatitis B, a virus that can cause long-term liver problems. If you have chronic, or long-lasting, Hepatitis B, this research might be of interest to you. Researchers are testing a new investigational drug called Imdusiran. An investigational drug means it's still being studied and is not yet approved for general use.

In this study, Imdusiran is being given alongside another medicine called Durvalumab, which is also known by its brand name, Imfinzi. Imfinzi is a type of drug that works with your immune system. The exciting part is that researchers are wanting to see if giving these two medicines together could offer a new, effective way to tackle Hepatitis B.

The main things the study aims to understand are the safety of this combination and how well people tolerate it. They will keep a close eye on any side effects and how the medicines affect your body. This kind of research is vital because it helps doctors and scientists learn more about new treatments, potentially leading to better health for people with chronic Hepatitis B in the future.

Key takeaways

Tests a new medicine (Imdusiran) with an existing one (Durvalumab) for Hepatitis B.
Aims to check safety, how well people tolerate it, and how it affects the body.
For adults aged 18 and over with long-term Hepatitis B.
Involves regular clinic visits, health checks, and blood tests.
Participation is voluntary, and you can withdraw at any time.
This is an early-stage study to gather important information.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years of age or older. There is no upper age limit, meaning older adults are welcome to participate if they meet other health requirements.

Both men and women can join the study. The researchers want to include a wide range of people to make sure the results are as helpful as possible for everyone living with Hepatitis B.

Beyond age and sex, there will be other specific health checks to make sure the study is a good fit for you and that it's safe for you to take part. For example, doctors will review your medical history and current health to determine if you meet all the criteria.

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 chronic (long-term) Hepatitis B?
Are you able to attend regular clinic appointments?
Are you willing to receive investigational (study) medications?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be part of an early-stage clinical trial looking into a new treatment for Hepatitis B. This means you will receive the study medications, Imdusiran and Durvalumab, according to a specific schedule decided by the research team. You will have regular appointments at the clinic for health checks, blood tests, and to make sure the treatment is going as planned.

These check-ups will involve things like monitoring your vital signs (such as blood pressure and heart rate), physical examinations, and possibly tests like an electrocardiogram (ECG) to check your heart. The medical team will be looking out for any side effects and how your body responds to the treatment. The total duration of your involvement, including regular visits and follow-up, will be explained in detail by the study team, but typically, studies like this involve several months of active treatment and monitoring.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. However, there are also potential risks, including side effects from the investigational medications, which might be mild or more serious. The research team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
France
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Unverified
Spain
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Unverified
Poland
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Unverified
Romania

Common questions

What is Hepatitis B?

Hepatitis B is a virus that infects the liver and can cause long-term health problems if not managed properly. This study is looking for new ways to treat it.

What does 'investigational drug' mean?

It means the medicine, Imdusiran, is still being tested in studies and is not yet approved for general use by the public. Researchers are gathering more information about its safety and effectiveness.

Will I know if I'm getting the active treatment?

This study is 'open-label', meaning that both you and the study team will know you are receiving the active study medications, Imdusiran and Durvalumab.

What kind of tests will I have?

You'll have regular health checks, blood tests to monitor your liver and how the medicine is working, and possibly heart tests like an ECG.

Do I have to pay to be in the study?

No, you will not have to pay for the study medications or study-related tests. Any travel expenses might also be covered, but you should confirm this with the study team.