Letermovir for CMV Prevention After Lung Transplantation (NCT05041426) | Clinical Trial Compass
CompletedPhase 2
Letermovir for CMV Prevention After Lung Transplantation
United States15 participantsStarted 2021-12-06
Plain-language summary
This is an interventional, open-label, single center, pilot study with historical controls to test the efficacy of letermovir (LET) for the prevention of CMV infection and disease in adult lung transplant recipients (LTRs) with idiopathic pulmonary fibrosis (IPF).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years on day of signing informed consent
* Listed for lung transplantation (single or double) due to a diagnosis of IPF or receipt of a lung transplant (single or double) for IPF in the 72 hours prior to enrollment
* Have a documented positive serostatus for CMV (CMV IgG seropositive, R+)
* Have a documented negative serostatus for CMV (CMV IgG seronegative, R-) and anticipate receiving or having received a lung allograft from a CMV IgG positive donor, D+). Only participants who are R+ or who are CMV D+/R- will receive intervention. Participants who are CMV D-/R- will be considered screen failures
* Able to travel to UPMC for routine post-transplant visits for a minimum of 15 months after transplantation
* Able to provide informed consent
* Be willing to use a contraceptive method while receiving LET and for at least 90 days following last dose of LET
Exclusion Criteria:
* Receipt of a previous solid organ transplant or hematopoietic stem cell transplant
* Multi-organ transplant recipient, i.e., heart-lung or lung-liver
* HIV seropositive
* HCV antibody or HCV RNA positive
* Donor HCV NAT positive
* Anticipated need for use of ganciclovir, valganciclovir, foscarnet, or cidofovir at the time of transplant
* Known or suspected hypersensitivity to LET or acyclovir
* CrCl \< 10 ml/min or dialysis on day of transplant
* Child-Pugh Class C severe hepatic insufficiency
* Pregnancy or expected to conceive while on LET and through at least 90 days foll…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of CMV Infection or Disease During Prophylaxis
Timeframe: 6-12 months post-transplant
2
Occurrence of CMV Infection or Disease in the 3 Months Following Completion of Prophylaxis
Timeframe: 12 weeks after completion of letermovir