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Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients

RecruitingPhase 4Ages 18 Years - anyAllUniversity Health Network, Toronto
NCT07235683 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Letermovir
  • Placebo
  • Valganciclovir/Ganciclovir
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Where

1 site
University Health Network, Toronto General Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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