Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients: A Pilot Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Canada
University Health Network, Toronto General Hospital
RECRUITING
Toronto
Contact Information
Primary
Atul Humar, MD, FRCPC
atul.humar@uhn.ca
416-340-4241
Time Frame
Start Date: 2025-12-24
Estimated Completion Date: 2027-08
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto