Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Cytomegalovirus Prophylaxis with Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study

This study is for adults who have recently received a heart transplant. After a transplant, patients can sometimes get a common infection called Cytomegalovirus (CMV), which can cause complications. This research is testing a medicine named PREVYMIS, which comes as a tablet you take by mouth. The main goal is to see how successful PREVYMIS is at preventing CMV infection in the first few months after a heart transplant. We also want to check for any side effects, like changes in blood cell counts, and see if the infection comes back later. This is an early-stage study to help us understand if this medicine is a good option for future use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Medical Center Ljubljana

Enrolment target

Start

17 Sep 2024

CMV infection in heart transplant recipients

What is this study about?

When you have a heart transplant, your body’s natural defence system (your immune system) needs to be carefully managed to stop it from rejecting the new heart. While this is happening, it can make you more vulnerable to certain infections. One very common infection that can affect people after an organ transplant is called Cytomegalovirus, or CMV for short.

CMV infection can cause problems, so doctors often give medicines to try and prevent it. This particular study is looking at a medicine called PREVYMIS. It's designed to stop the CMV virus from causing an infection. By taking part, we want to find out if PREVYMIS 240 mg tablets are effective at preventing CMV in the early months after a heart transplant, and also to learn more about how people tolerate the medicine and if there are any side effects.

This kind of study helps doctors understand better ways to care for people after a heart transplant, aiming to reduce the risk of infections and improve recovery. The information gathered will be very useful in deciding if PREVYMIS could be a standard treatment in the future to help people stay healthier after their life-changing surgery.

Key takeaways

This study looks at preventing CMV infection in heart transplant patients.
It tests a medicine called PREVYMIS taken as a tablet.
The main aim is to see how well PREVYMIS prevents CMV and if it causes side effects.
Participants will be closely checked with regular blood tests.
This is an early study to improve care for people after heart transplants.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning people of any age above 18 can be considered.

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 recently had a heart transplant?
Are you able to take tablets by mouth?
Are you willing to have regular medical checks and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the study medicine, PREVYMIS 240 mg tablets, to take by mouth. You would take this medicine for a set period after your heart transplant as a way to prevent CMV. The study team would closely monitor you. This would involve regular visits to the hospital, likely including blood tests, to check for any signs of CMV infection or side effects from the medicine. You would also be checked for some months after you stop taking the study medicine. The total length of your participation, including follow-up, would be determined by the study plan, but it would involve regular checks and assessments to keep an eye on your health.

Potential risks and benefits

Taking part in this study could potentially help prevent CMV infection after your heart transplant, which could lead to a smoother recovery. However, like all medicines, PREVYMIS can have side effects, and some people might experience them. We will be carefully monitoring you for any side effects, including changes in your blood count. It's important to remember that you are free 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.

—
Unverified
Slovenia

Common questions

What is CMV?

CMV (Cytomegalovirus) is a common virus that most people carry without knowing it. However, if your immune system is weaker, like after a heart transplant, it can cause problems and illness.

What is PREVYMIS?

PREVYMIS is a medicine specifically designed to help prevent your body from developing a CMV infection.

Why is this study important?

This study helps us learn if PREVYMIS is a good and safe way to protect heart transplant patients from CMV infection, potentially making their recovery easier.

Will I get the actual medicine or a dummy pill?

In this particular study, all participants will receive the active study medicine, PREVYMIS, as it's testing a specific preventative treatment.

How long will I be in the study?

The study involves taking the medicine for a period after your transplant and then having follow-up checks for several months afterwards. The study team can give you a more precise timeline.