RecruitingPHASE4INTERVENTIONAL

Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients

If you've had a lung transplant, you might be at risk of getting a common virus called Cytomegalovirus (CMV). This can cause problems and even damage your new lung. Doctors usually treat CMV with certain medicines, but sometimes these have side effects or don't work as well as hoped. This study is testing if adding a newer drug called Letermovir to the usual treatment helps clear the CMV virus more quickly and effectively in lung transplant patients. Letermovir has been used to prevent CMV before, but this study explores its use as part of a treatment alongside existing medicines. We want to find out if this combination could be a better way to manage CMV infections for people like you.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University Health Network, Toronto

Enrolment target

Start

24 Dec 2025

Estimated completion

01 Aug 2027

CMV Lung Transplant Recipient

What is this study about?

When someone has a lung transplant, they need to take special medicines to stop their body from rejecting the new lung. These medicines, while very important, can also weaken their immune system, making them more likely to get infections. One common infection is from a virus called Cytomegalovirus, or CMV. For lung transplant patients, CMV can cause serious problems, including inflammation in the lungs and even long-term damage to the transplanted organ.

Currently, doctors mainly use a medicine called ganciclovir, or its tablet form valganciclovir, to treat CMV. While these medicines often work, they can sometimes cause unwanted side effects or not be strong enough for everyone. This is where a newer medicine, Letermovir, comes in. Letermovir works differently to ganciclovir. It has been used to prevent CMV attacks in other patient groups, but we're now investigating if it can help treat an active CMV infection, especially when used alongside the standard medicines.

This study, called CLEAR-CMV, aims to see if giving Letermovir together with the usual CMV treatment is better at getting rid of the virus by three weeks compared to just using the standard treatment with a dummy pill (placebo). The idea is that by using two different medicines that attack the virus in different ways, we might achieve a stronger response and help patients clear the infection more quickly and safely. This could potentially lead to better health outcomes for lung transplant patients with CMV.

Key takeaways

This study tests a new combination treatment for CMV in lung transplant patients.
It aims to see if adding Letermovir to standard care clears the virus better.
Participation involves taking study medication and regular check-ups for about three weeks.
You might benefit from a more effective treatment, but there are always potential risks.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you must have had a lung transplant. You also need to have an active CMV infection, which means the virus has been detected in your blood at a certain level. You'll either be just starting the usual CMV treatment or have started it very recently (within the last three days).

There are also some reasons why you wouldn't be able to join the study. For example, if you have severe kidney or liver problems, or if you're already taking part in another study that involves new treatments. We also can't include people who have had more than a lung transplant, such as a heart-lung transplant.

It's important that you don't have any known allergies to the study medicines. Also, if your body has developed resistance to current CMV treatments or if you're taking certain medicines that could react badly with Letermovir, you wouldn't be able to participate. This includes certain medicines for transplant rejection or other specific conditions.

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.

Have you had a lung transplant?
Do you currently have an active CMV infection (virus detected in your blood)?
Are you just starting or have you recently started (in the last 3 days) standard CMV treatment?
Do you have severe kidney or liver problems?
Are you allergic to any antiviral medications?
Are you taking cyclosporin, pimozide, or ergot alkaloids?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups. One group will receive Letermovir tablets alongside your standard CMV treatment, and the other group will receive a dummy pill (placebo) with your standard CMV treatment. You and your doctors won't know which group you are in. You'll take these medicines for an initial three-week period. During this time, you'll have regular visits to the clinic for blood tests to check your CMV levels and overall health. Your doctor will carefully monitor you for any side effects and ensure the treatment is tolerated well. The total duration of your active participation in the study, including follow-up, will be determined by your treating physician based on your response to treatment and will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of a more effective treatment for your CMV infection, which could help you recover faster and potentially reduce long-term complications. However, there's no guarantee that the new treatment will be better for you than standard care. All medications carry risks, and you might experience side effects from the study drugs, including those from Letermovir, or from the combination of medicines. These will be thoroughly explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Health Network, Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is CMV?

CMV is a common virus that can affect people, especially those with weakened immune systems, like lung transplant patients.

What is Letermovir?

Letermovir is a newer antiviral medicine. It works differently from older CMV drugs and has been used to prevent CMV infections.

Will I still get my usual CMV treatment?

Yes, everyone in the study will receive standard CMV treatment with ganciclovir or valganciclovir, plus either Letermovir or a dummy pill.

Why is combination therapy important?

Using two different medicines might attack the virus more effectively and reduce the chance of it becoming resistant to treatment.

What is a placebo?

A placebo is an inactive pill that looks just like the study drug but contains no medicine. It's used to fairly compare the new treatment's effects.

How to find out more

Atul Humar, MD, FRCPC

atul.humar@uhn.ca 416-340-4241 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.