Active not recruitingNAINTERVENTIONAL

Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection

This study aims to find out which patients with Hepatitis Delta can safely stop taking the medicine Bulevirtide. Currently, doctors don't know exactly how long people need to take this drug, and there's a risk the infection could return if stopped too soon. Researchers will look for clues, called biomarkers, in blood and liver samples from patients who have been doing well on Bulevirtide for at least 48 weeks. They will then stop the treatment and monitor these patients closely. The goal is to identify specific biomarkers that can predict if a patient will remain well after stopping treatment, or if their infection might come back. This information will help doctors decide who can safely stop the medicine, potentially reducing long-term treatment and costs.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hannover Medical School

Enrolment target

Start

30 Sep 2024

Estimated completion

30 Jun 2026

Compensated Liver Disease (Disorder)Hepatitis D, Chronic

What is this study about?

This study is about an important question for people living with chronic Hepatitis D infection: how do we know when it's safe to stop current treatments? One of these treatments is a medicine called Bulevirtide. Right now, doctors don't have clear guidelines on how long patients should take Bulevirtide. Some patients have been able to stop the drug in previous small studies and their infection remained under control, but doctors don't know why this happens for some and not others.

This research aims to find specific clues, called biomarkers, in your blood or liver that can help predict if your Hepatitis D infection will stay under control after you stop taking Bulevirtide. These biomarkers could be like unique signals that tell doctors who is likely to remain well without the medicine. Finding these signals is crucial because if your infection returns after stopping treatment, it could lead to serious health problems.

The main goal is to make treatment safer and more personalised. If doctors can identify who can safely stop Bulevirtide, it means some patients might not need to take the medicine for their whole lives. This could reduce the burden of long-term treatment, potential side effects, and overall healthcare costs, while ensuring you remain healthy. This study is a careful step towards understanding this better.

Key takeaways

Tests for clues (biomarkers) to help doctors decide when it's safe to stop Bulevirtide treatment for Hepatitis D.
Aims to predict if your infection will stay controlled after treatment stops.
Could reduce the need for lifelong medication for some patients.
Involves stopping Bulevirtide and being carefully monitored.
Only for patients already taking and doing well on Bulevirtide.

Who may be eligible?

To join this study, you need to be at least 18 years old, and have a chronic Hepatitis D infection. You must already be taking Bulevirtide treatment and have been on it for at least 48 weeks. Importantly, your Hepatitis D infection needs to have been well-controlled by Bulevirtide for at least 24 weeks, meaning the level of the virus in your blood is very low.

You also need to be taking stable treatment for any underlying Hepatitis B infection you might have. If you've had previous treatments like interferon or medicines that lower your immune system, you need to have stopped them at least 6 months before starting Bulevirtide.

However, you can't join if you have severe liver disease (like advanced cirrhosis) or have had liver cancer. You also can't participate if you have very low blood platelet counts, are currently in another medical trial, or if your doctor believes it's not safe for you to stop Bulevirtide for any other reason.

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 Hepatitis D?
Have you been taking Bulevirtide for at least 48 weeks?
Is your Hepatitis D infection well-controlled by Bulevirtide (low virus levels) for at least 24 weeks?
Do you NOT have severe liver damage, liver cancer, or very low blood platelets?
Are you NOT currently part of another interventional medical study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue taking Bulevirtide for a total of at least 48 weeks. During this time, your doctors will take blood and possibly liver samples to look for specific markers that show how your body is responding to treatment. After this initial period, if your Hepatitis D infection is well under control, you will then stop taking Bulevirtide.

After stopping the medicine, you will be carefully watched and have regular check-ups, blood tests, and possibly more liver samples. The researchers will be looking to see if your Hepatitis D infection stays controlled without the medicine, or if it starts to come back. The overall duration of your participation in the study will depend on how long you've been on Bulevirtide and how long you need to be monitored after stopping.

Potential risks and benefits

A potential benefit of taking part is that we might learn more about safely stopping Bulevirtide treatment, which could reduce the need for lifelong medication for you and others in the future. However, there's always a risk that your Hepatitis D infection could return or get worse after you stop Bulevirtide. The study team will monitor you closely to catch any issues early. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (5)

University Hospital Heidelberg; Department of Internal Medicine IV: Gastroenterology, Hepatology, Infectious Diseases, Poisoning
Verified postcode
Heidelberg, Germany
University Hospital Frankfurt; Medical Clinic 1
Verified postcode
Frankfurt am Main, Germany
Hannover Medical School; Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology
Verified postcode
Hanover, Germany
Charité - University Hospital Berlin (Campus Virchow-Clinic); Department of Hepatology and Gastroenterology
Verified postcode
Berlin, Germany
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Division of Gastroenterology and Hepatology
Verified postcode
Milan, Italy

Common questions

What is a 'biomarker'?

A biomarker is like a sign or clue in your body, often found in blood or tissue samples, that can tell us about your health or how your body is responding to treatment.

What is Hepatitis D?

Hepatitis D is a serious liver infection caused by a virus. It only affects people who also have Hepatitis B.

What is Bulevirtide?

Bulevirtide is a medicine used to treat chronic Hepatitis D infection.

Will I have to stop my Hepatitis B treatment?

No, you must continue taking your stable Hepatitis B treatment throughout the study period.

Will I receive new medicine in this study?

No, this study is about stopping an existing medicine (Bulevirtide) to see who can safely do without it, rather than trying a new drug.