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Can a Two-Drug punch knock out CMV faster in lung transplants?

NCT ID NCT07235683

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding letermovir to standard antiviral treatment helps clear cytomegalovirus (CMV) infection faster in people who have received a lung transplant. About 40 participants will receive either letermovir or a placebo alongside their usual medication for 21 days. The main goal is to see if more patients achieve a negative CMV test by week three.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Letermovir (an antiviral drug) plus standard antiviral therapy (valganciclovir/ganciclovir)
What this could lead to
If successful, this combination could help lung transplant patients clear CMV infections more quickly, reducing complications and improving recovery.
What could go wrong
This is a small pilot trial with only 40 participants, so results may not apply broadly. Adding letermovir could also increase side effects or drug interactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Recipient of a lung transplant. * Has confirmed CMV viremia with a viral load ≥ 1000 IU/mL and will receive or has just started SOC antiviral treatment in the past 72h as per the decision of the treating physician. Exclusion Criteria: * Renal failure with Creatinine clearance \<15 mL/min or requiring dialysis * Severe hepatic impairment (Child-Pugh Class C) * Participating in another interventional clinical trial * Combined transplant (e.g heart-lung, lung-liver) * Known allergy or contraindication to any of the antiviral medications * Known antiviral resistance. * Patient receiving cyclosporin, pimozide or ergot alkaloids (due to significant drug interaction with letermovir). * Patient receiving or expected to receive CMV immunoglobulin or IVIG during the initial three week treatment phase

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CMV Lung transplant recipient

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Health Network, Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

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