Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

HepBTer: From fungus to virus, a phase 2a clinical trial investigating the safety and efficacy of terbinafine in chronic hepatitis B patients

The HepBTer study is a research project looking into a medicine called terbinafine for people who have chronic (long-lasting) hepatitis B. Hepatitis B is a virus that can affect the liver. In this study, doctors want to find out if terbinafine is safe to use and if it can help reduce the amount of the hepatitis B virus in people's bodies. They are also checking if it can lower certain markers related to the virus. Participants will take either the study medicine or a placebo (a dummy pill) for 10 weeks. This is an early phase of testing to see if the medicine shows promise before larger studies are done.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Stichting Amsterdam UMC

Enrolment target

Start

25 Jul 2024

Chronic hepatitis B

What is this study about?

The HepBTer study is an important research project designed to explore a new potential treatment for chronic hepatitis B. Chronic hepatitis B means that the hepatitis B virus stays in a person's body for a long time, which can sometimes lead to liver problems if not managed. This study is focusing on a medicine called terbinafine, which is currently used for fungal infections but researchers are now investigating if it could also work against certain viruses.

The main goal of this study is to see if terbinafine is safe for people with chronic hepatitis B and if it can help to lower the amount of the virus in their blood. Researchers will be looking at specific markers in the blood that tell them how much virus is present and how active it is. They will compare results from people taking terbinafine with those taking a placebo, which looks like the medicine but contains no active drug. This helps them understand if any changes are due to the active medicine.

This is an early-stage study, known as a Phase II trial. This means it's a step before larger studies are conducted. The information gathered from HepBTer will help doctors decide if terbinafine is a promising treatment for chronic hepatitis B and whether it should be studied further in more people.

Key takeaways

The HepBTer study is testing an existing medicine, terbinafine, for chronic hepatitis B.
It aims to see if terbinafine is safe and can reduce the amount of the virus in your body.
Participants will take either terbinafine or a placebo for 10 weeks.
This is an early-stage study to gather initial information.
Regular health checks and blood tests will be part of taking part.

Who may be eligible?

To join the HepBTer study, you must be an adult aged 18 or older. There is no upper age limit, meaning people of all adult ages can be considered.

Both men and women are welcome to take part in this study. The researchers are looking for a diverse group of participants to get a broad understanding of how the medicine might work.

Since this study is specifically for people with chronic hepatitis B, you would need to have this condition to be considered. Your doctor or the study team would check your medical records and perform some tests to confirm you meet all the specific health requirements for the study.

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-lasting) hepatitis B?
Are you able to attend regular clinic appointments?
Are you comfortable potentially receiving a placebo (dummy pill)?

Answer every question to see your result.

What does participation involve?

If you decide to join the HepBTer study, you will be taking either the study medication (terbinafine) or a placebo (a dummy pill) for a period of 10 weeks. The medication will be in the form of capsules or tablets, and you will take 250 mg daily. The study is designed so that neither you nor your doctor will know whether you are receiving the active medicine or the placebo. This is a common practice in research to ensure fair and unbiased results.

During these 10 weeks, you will have regular visits to the clinic. At these visits, the study team will monitor your health carefully. This will involve physical examinations, blood tests to check how the medicine is affecting your body and the virus levels, and questions about how you are feeling. These checks are important to make sure the treatment is safe for you and to see if it's having any effect.

After the 10 weeks of treatment, there will likely be follow-up visits to ensure your health remains stable and to collect any final data. The total duration of your involvement in the study, including screening, treatment, and follow-up, will be clearly explained by the research team.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical attention from a specialist team. You might also gain a better understanding of your condition. However, there are also potential risks, including side effects from the study medication, or the possibility that the treatment may not help your condition or could be a placebo. All known risks will be thoroughly explained to you before you decide to take part. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is chronic hepatitis B?

Chronic hepatitis B is a long-lasting infection caused by the hepatitis B virus, which can affect your liver. It means the virus has stayed in your body for more than six months.

What is terbinafine?

Terbinafine is a medicine that is usually used to treat fungal infections. In this study, doctors are investigating if it could also help people with chronic hepatitis B.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the study medicine but contains no active drug. It helps researchers compare results fairly to see if the real medicine is effective.

How long will I be in the study?

You'll be taking the study medicine (or placebo) for 10 weeks. This will involve regular clinic visits for checks, and there might be follow-up visits after the 10 weeks.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make sure the study results are as accurate as possible.