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Study on Letermovir for Preventing CMV Infection in Lung Transplant Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition that affects patients who have received a lung transplant. Specifically, it looks at preventing a virus called CMV (Cytomegalovirus) from causing infections in these patients. The study is comparing two different treatments: one group of patients will receive a medication called letermovir, which is also known by its code name MK-8228, while another group will be compared based on past records of patients who were treated with a standard medication called valganciclovir.

The purpose of the study is to evaluate how effective letermovir is in preventing CMV infections in lung transplant recipients over a period of 12 months. Participants in the study will take letermovir in the form of film-coated tablets, and their health will be monitored to see if the medication helps in reducing the incidence of CMV disease. The study will also look at other factors such as any side effects from the medications, including potential issues like leukopenia, which is a condition where the number of white blood cells is lower than normal, and renal toxicity, which refers to kidney problems that might arise from the treatment.

Throughout the study, researchers will keep track of any hospital readmissions due to CMV complications and any other infections that might occur. The study aims to provide valuable information on whether letermovir is a better option for preventing CMV infections in lung transplant patients compared to the standard treatment with valganciclovir.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that you meet the eligibility criteria. You must be 18 years or older and a lung transplant patient with a specific donor and recipient status (D+/R-).

    You will need to have an undetectable PCR-CMV test result within 96 hours before starting the medication. Written informed consent is required to participate.

  2. Step 2

    Starting medication

    Begin taking the medication letermovir as prescribed. This medication is provided in the form of PREVYMIS 240 mg film-coated tablets.

    The medication is taken orally and is part of a 12-month prophylaxis plan to prevent CMV infection.

  3. Step 3

    Regular follow-up

    Attend regular follow-up appointments as scheduled by the study team. These appointments are crucial for monitoring your health and the effectiveness of the medication.

    During these visits, any side effects or changes in your health will be assessed, and adjustments to your treatment plan may be made if necessary.

  4. Step 4

    Monitoring for CMV

    Throughout the 12-month period, the incidence of CMV disease or replication will be closely monitored.

    Additional tests may be conducted to ensure that the medication is effectively preventing CMV infection.

  5. Step 5

    Completion of the study

    After completing the 12-month medication regimen, a final assessment will be conducted to evaluate the overall effectiveness of the treatment.

    Your participation in the study will help in understanding the efficacy of letermovir prophylaxis in preventing CMV infection in lung transplant recipients.

Who can join the trial?

7 criteria

  • Must be 18 years or older.
  • Must be a lung transplant patient who is a donor positive/recipient negative (D+/R-) before the transplant.
  • Must have an undetectable PCR-CMV test result within 96 hours before starting letermovir prophylaxis.
    (PCR-CMV is a test to check for the presence of a virus called cytomegalovirus in the blood.)
  • Must have given written informed consent to participate in the study.
    (This means you agree to join the study after being informed about it.)
  • For the retrospective group, must have been treated with valganciclovir prophylaxis for 12 months.
    (Valganciclovir is a medication used to prevent viral infections.)
  • For the retrospective group, must have been transplanted in the 2 years before the study started.
  • For the retrospective group, must have a complete follow-up of 13 months with data comparable to the prospective group.
    (This means having enough information to compare with those currently being studied.)

Who cannot join the trial?

4 criteria

  • Patients who have not received a lung transplant.
  • Patients who are not in the D+/R- group. This means the donor was positive for a certain virus, and the recipient was negative.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Letermovir

    is a medication used in this clinical trial to help prevent a type of viral infection called CMV, which can occur after a lung transplant. CMV is a virus that can cause serious illness in people with weakened immune systems, like those who have had a transplant. Letermovir works by stopping the virus from multiplying in the body, which helps to prevent the infection from developing.

  • Valganciclovir

    is another medication used in this study, but it is part of a comparison group from the past. It is also used to prevent CMV infections in people who have had a lung transplant. Valganciclovir works by interfering with the virus's ability to reproduce, which helps to keep the infection from becoming serious. This medication has been used as a standard treatment to prevent CMV in transplant patients.

What is already known about the treatment

  • Letermovir

    Letermovir is administered orally or intravenously and is used to prevent cytomegalovirus (CMV) infection in patients who have received a lung transplant. It is currently being studied for its effectiveness compared to the standard treatment, valganciclovir, in preventing CMV disease in these patients. Letermovir works by inhibiting the CMV DNA terminase complex, which is essential for viral replication. It is classified as an antiviral medication.

  • Valganciclovir

    Valganciclovir is an oral medication used to prevent CMV infection in lung transplant patients. It is part of the standard treatment regimen and is being compared to letermovir in clinical trials to assess its effectiveness over a 12-month period. Valganciclovir works by inhibiting viral DNA synthesis, which prevents the virus from multiplying. It is classified as an antiviral medication.

Investigated diseases

Cytomegalovirus Infection – Cytomegalovirus (CMV) infection is caused by the CMV virus, which is a type of herpesvirus. It often remains dormant in the body after the initial infection, which may not cause noticeable symptoms. In individuals with weakened immune systems, such as lung transplant recipients, the virus can reactivate and lead to more serious complications. The progression of CMV infection can include symptoms like fever, fatigue, and muscle aches, and it may affect various organs. In severe cases, it can lead to inflammation of the lungs, liver, or other organs. The disease can also cause complications such as leukopenia, which is a reduction in white blood cells, making the body more susceptible to other infections.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504384-16-00Protocol codeFCO-LET-2022-01Estimated enrolment70 patientsSponsorFundacion Para La Investigacion Biomedica De Cordoba

sourced from the EU Clinical Trials Register and site verification

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