Active not recruitingOBSERVATIONAL

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

This study is gathering information on a medicine called bulevirtide, used to treat chronic hepatitis D infection. Doctors want to learn more about its long-term effects and whether it's safe for patients. Some participants will have already been part of a previous study and are currently taking bulevirtide. Others will be starting bulevirtide treatment soon. By collecting this information, researchers hope to get a better picture of how bulevirtide helps people manage their chronic hepatitis D in the long run. This information is important for understanding the real-world use of the medicine.

At a glance

Status

Active not recruiting

Sponsor

Gilead Sciences

Enrolment target

170

Start

07 Feb 2023

Estimated completion

01 Jul 2028

Chronic Hepatitis D Infection

What is this study about?

This research study is all about learning more about a medicine called bulevirtide, which is used to treat a long-lasting liver condition called chronic hepatitis D. When a new medicine becomes available, doctors and researchers want to keep a close eye on how it works for patients in their everyday lives, once it's been approved for use. This helps them understand its benefits and any possible side effects over a longer period than initial trials.

The main goal here is to collect information from people who are taking, or are going to take, bulevirtide. Researchers want to see how the medicine affects them over time. This includes looking at how well it helps with their hepatitis D and checking for any safety concerns. This kind of study is really important because it helps medical professionals gain a full understanding of treatments once they are readily available to patients.

Some people taking part in this study will have already been involved in an earlier research project and are continuing their bulevirtide treatment. Others will be people who are just about to start taking bulevirtide as part of their standard care. By including both groups, the researchers can get a broad view of the medicine's effects, ensuring they gather comprehensive data on its long-term impact on people with chronic hepatitis D.

Key takeaways

This study is observing how bulevirtide works for people with chronic hepatitis D.
It aims to understand the long-term effects and safety of the medicine.
Participants are either continuing bulevirtide from a previous study or starting it as new treatment.
The study collects information from your regular medical care, not by giving new experimental treatments.
It helps doctors learn more about bulevirtide in real-world use.

Who may be eligible?

To join this study, you generally need to be an adult (18 or older) with chronic hepatitis D infection that has been confirmed for at least six months. You also need to be able to understand the study information and be willing to follow the study plan, including attending any necessary appointments.

There are a few reasons why you might not be able to join. For example, if you are currently taking part in other studies involving new medicines, or if you have certain other serious health problems. This also includes conditions like advanced liver disease, a history of liver failure, or if you have or have recently had certain types of liver cancer.

It's also important that you don't have other long-lasting liver infections like hepatitis C (unless the virus is completely cleared) or HIV. If you've had an organ transplant, are pregnant or breastfeeding, or have a severe COVID-19 infection, you also wouldn't be able to take part. Finally, if you're allergic to bulevirtide, then this study wouldn't be suitable for you.

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.

I am 18 years old or older.
I have been diagnosed with chronic hepatitis D for at least 6 months.
I do not have active hepatitis C or HIV infections.
I have not had a liver transplant.
I am not pregnant or breastfeeding.
I am not currently severely ill with COVID-19.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be giving researchers information about your experience with bulevirtide. For some people, this will involve looking back at their medical records from when they were in a previous study and tracking their progress going forward while they continue bulevirtide treatment. For others who are just starting bulevirtide, it means their health and treatment will be monitored over time.

The study aims to gather data from your regular doctor's visits and check-ups related to your hepatitis D and bulevirtide treatment. This helps researchers understand the long-term effects and safety of the medicine in real-world situations. The exact number of visits, tests, or how long you'll be involved will depend on whether you're already on bulevirtide or just starting, and what your doctor usually recommends for your condition. Your medical information will be collected as you continue your treatment.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to a better understanding of bulevirtide, which could help future patients with chronic hepatitis D. You will continue to receive your bulevirtide treatment as prescribed by your doctor. The main risks involved are those typically associated with bulevirtide treatment itself, which your doctor would discuss with you. There are no additional experimental medicines given in this study. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (53)

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

Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie
Verified postcode
Graz, Austria
Aö Landeskrankenhaus Hall
Verified postcode
Hall in Tirol, Austria
Universitätsklinik für Innere Medizin I Innsbruck
Verified postcode
Innsbruck, Austria
Medizinische Universitat Wien
Verified postcode
Vienna, Austria
Centre Hospitalier Universitaire D'Angers
Verified postcode
Angers, France
Hôpital Avicenne - APHP
Verified postcode
Bobigny, France
Hopital Beaujon
Verified postcode
Clichy, France
Hôpitaux Universitaires Henri Mondor
Verified postcode
Créteil, France
CHU Grenoble Alpes
Verified postcode
Grenoble, France
Centre Hospitalier Universitaire De Lille- Hôpital Huriez
Verified postcode
Lille, France
CHU de Limoges - Hopital Dupuytren
Verified postcode
Limoges, France
Hôpital de la Croix-Rousse
Verified postcode
Lyon, France

Common questions

What is chronic hepatitis D?

It's a long-lasting liver infection caused by the hepatitis D virus, which can only affect people who also have hepatitis B.

What is bulevirtide?

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

Will I receive new treatment in this study?

No, this study observes how bulevirtide works in real life. You'll receive bulevirtide if your doctor prescribes it.

Who is running this study?

This study is gathering 'post-marketing data,' meaning information collected after a medicine has been approved and is available for use.

What if I change my mind about participating?

You are free to leave the study at any time, and it won't affect the care you receive from your doctor.