Letermovir plus standard antiviral to clear CMV in lung transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4, randomized, placebo-controlled trial comparing letermovir plus standard-of-care (ganciclovir/valganciclovir) versus placebo plus standard-of-care in lung transplant recipients with active CMV viremia. Eligible participants have confirmed CMV viremia ≥1,000 IU/mL and have started standard antiviral therapy within the past 72 hours. The primary endpoint is clearance of CMV viremia by week 3, with safety monitored given prior concerns about myelosuppression from standard antivirals. The trial is being conducted at the University Health Network (Toronto General Hospital).

Why it matters

Who can join: the full rules

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

Where it's running

• University Health Network, Toronto General Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Atul Humar, MD, FRCPC
• Email: atul.humar@uhn.ca
• Phone: 416-340-4241

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.