AuthorisedTherapeutic use (Phase IV)Interventional

A phase IV proof-of-concept study to assess the safety and efficacy of Maribavir to inhibit high Virus Epstein-Barr (VEB) replication among young adult kidney transplant recipie

This research study is for young adults, aged 18 and over, who have received a kidney transplant and are experiencing high levels of the Epstein-Barr virus (EBV). EBV is a common virus that can cause problems for people with weakened immune systems, like transplant patients. The study is testing a medicine called Maribavir, also known as LIVTENCITY, to see how well it helps clear this virus from the body and if it is safe to use. This is a Phase IV study, meaning the medicine is already approved for some uses, but doctors want to learn more about its benefits and safety in this specific group of patients. The main goal is to find out how many patients get rid of the virus completely after taking Maribavir.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Enrolment target

Start

13 May 2026

Transplant patients with high recurrent Epstein-Barr infection

What is this study about?

This study is about helping young adults who have received a kidney transplant and are struggling with a high amount of the Epstein-Barr virus (EBV) in their bodies. EBV is a very common virus, and most people catch it at some point. For healthy people, it often causes no symptoms or just a mild illness like glandular fever. However, for people whose immune systems are weakened, such as those who have had an organ transplant, EBV can become a more serious problem. It can lead to health complications because their body can't fight it off as easily.

The researchers are looking specifically at a medicine called Maribavir, also known by its brand name LIVTENCITY. This medicine is designed to stop viruses from multiplying. While Maribavir is already approved for treating a different type of virus in transplant patients, doctors want to understand if it can also be an effective and safe treatment for EBV in young adult kidney transplant recipients. This is important because finding better ways to manage EBV could improve the health and well-being of these patients.

The main thing the study wants to find out is how many patients taking Maribavir are able to completely clear the Epstein-Barr virus from their bodies. They will also look at how quickly the virus levels go down, if patients need more medicine, whether the virus returns after treatment, and how the medicine affects their immune system's ability to fight EBV. All these details will help doctors understand the full picture of how Maribavir works for this specific group of patients.

Key takeaways

This study is testing a medicine called Maribavir for Epstein-Barr virus in kidney transplant patients.
It aims to see how well the medicine clears the virus and if it's safe.
Participants will take Maribavir tablets and have regular check-ups.
Only young adults aged 18 and over with a kidney transplant and high EBV levels can join.
This research could lead to better treatments for EBV in transplant patients.

Who may be eligible?

This study is looking for young adults who are 18 years old or older. There is no upper age limit, so you can be any age above 18 to take part. Both men and women can join this study.

The most important thing is that you must have already had a kidney transplant. In addition to that, you need to have been diagnosed with a high level of the Epstein-Barr virus (EBV) in your system. This means your doctors have found a significant amount of the virus and are concerned about it.

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?
Have you had a kidney transplant?
Have your doctors told you that you have a high amount of the Epstein-Barr virus (EBV) in your system?
Are you male or female?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking a medicine called Maribavir (LIVTENCITY). This comes in tablet form, and you would take 200mg. To see how well the treatment is working and to check your general health, you would have regular visits with the study team. These visits will involve blood tests to measure the amount of EBV in your body and to check for any side effects from the medication. The study will monitor your progress over a period, looking at how the virus levels change, if the virus stays away after you finish the medicine, and how your immune system responds. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer the benefit of receiving a new treatment that could help manage your Epstein-Barr virus infection more effectively than current options. This could potentially improve your overall health after your kidney transplant. However, as with any medicine, there are potential risks, including side effects from Maribavir. The study team will closely monitor you for any side effects, and you will be given detailed information about them. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Spain

Common questions

What is the Epstein-Barr virus (EBV)?

EBV is a very common virus, most people catch it. In healthy people, it might cause glandular fever or no symptoms, but for transplant patients, it can be more serious.

What is Maribavir (LIVTENCITY)?

Maribavir, also called LIVTENCITY, is a medicine designed to stop viruses from multiplying in your body. It's being tested to see if it works for EBV in kidney transplant patients.

Why is this study only for kidney transplant patients?

Transplant patients have weaker immune systems due to their anti-rejection medicines, which can make EBV more problematic. This study specifically looks at how the medicine works for them.

What does 'Phase IV' mean?

A Phase IV study means the medicine is already approved for some uses, but doctors want to learn more about its effects and safety in specific groups of patients or for other conditions.

Will I get the medicine if I join?

Yes, if you join this study, you would receive the study medicine, Maribavir (LIVTENCITY), as part of the research protocol.