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New treatment option for CMV
Official title Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients
ClinicalTrials.gov ID: NCT07235683
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cmv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Renal failure with Creatinine clearance \<15 mL/min or requiring dialysis
- Severe hepatic impairment (Child-Pugh Class C)
- Participating in another treatment clinical trial
- Combined transplant (e.g heart-lung, lung-liver)
- Known allergy or contraindication to any of the antiviral medications
- Known antiviral resistance.
See the full eligibility 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.
- Renal failure with Creatinine clearance \<15 mL/min or requiring dialysis
- Severe hepatic impairment (Child-Pugh Class C)
- Participating in another treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.