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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Letermovir
  • Placebo
  • Valganciclovir/Ganciclovir

Treatment groups

40 Participants
are divided into 2 treatment groups