Recruiting

Letermovir with SOC

Sponsor:

University Health Network, Toronto

Code:

NCT07235683

Conditions

CMV

Lung Transplant Recipient

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Letermovir

Placebo

Valganciclovir/Ganciclovir

Study Details

Brief summary:

The primary objective of the CLEAR-CMV trial is to evaluate the efficacy of letermovir therapy plus standard of care (SOC) antiviral compared to SOC plus placebo in achieving clearance of CMV viremia by week 3 in lung transplant recipients with active CMV infection.

Conditions

CMV

Lung Transplant Recipient

Study ID

NCT07235683

Start date

Dec 24, 2025

Status verified date

Feb, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: SOC antiviral plus placebo

Patients will receive the standard of care (SOC) antiviral therapy along with a placebo drug. The placebo drug will be administered for three weeks, while the SOC antiviral duration and dosage will be at the discretion of the treating physician.

experimental: SOC antiviral plus letermovir active drug

Patients will receive the standard of care (SOC) antiviral therapy in combination with letermovir. The letermovir active drug will be administered for three weeks, while the SOC antiviral treatment duration and dosage will be at the discretion of the treating physician.

Interventions

Letermovir

Letermovir (480mg) will be given orally as a loading dose every 12 hours for the first 24 hours, then one tablet per day for a total treatment duration of 21 days. Letermovir treatment will be started within 72 hours of starting SOC antiviral treatment as per the decision of the treating physician.

Placebo

Placebo will be dosed the same as letermovir: one tablet every 12 hours for the first 24 hours, then one tablet per day for total treatment duration of 21 days.

Valganciclovir/Ganciclovir

Ganciclovir or its oral prodrug, valganciclovir will be administered as the standard of care antiviral therapy. Its duration will be at the discretion of the treatment physician but is typically given until clearance of viremia. The clinical definition of viral clearance is one negative viral load or two viral loads one week apart that are <200 IU/mL

Primary outcome measure

  • Proportion of patients achieving clearance of CMV viremia by week 3, as measured by quantitative PCR. [ Time Frame: From time of enrollment until 3 weeks after enrolment ]

Central Contacts and Locations

Central contacts

Atul Humar, MD, FRCPC

416-340-4241atul.humar@uhn.ca

Locations

University Health Network, Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Ilona Bahinskaya, MSc, CCRP

416-340-4800Ilona.Bahinskaya@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • CMV Disease
  • Lung Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-02-17.