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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-12-24 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07235683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CMV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07235683 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07235683 currently recruiting?
Yes, NCT07235683 is actively recruiting participants. Contact the research team at atul.humar@uhn.ca for enrollment information.
Where is the NCT07235683 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07235683 clinical trial?
NCT07235683 is sponsored by University Health Network, Toronto. The trial plans to enroll 40 participants.