NCT07235683 Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients
| NCT ID | NCT07235683 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Health Network, Toronto |
| Condition | CMV |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-24 |
| Primary Completion | 2027-08 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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