NCT05041426CompletedPhase 2
Letermovir for CMV Prevention After Lung Transplantation
An Open-label Pilot Protocol to Evaluate the Efficacy of Letermovir for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Lung Transplant Recipients With Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 20 Apr 2021
- Start date
- Dec 2021
- Primary completion date
- Mar 2025
- Lead sponsor
- Fernanda P Silveira, MD, MS
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT05041426
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 15
- From Dec 2021 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of a previous solid organ transplant or hematopoietic stem cell transplant
- Anticipated need for use of ganciclovir, valganciclovir, foscarnet, or cidofovir at the time of transplant
- CrCl \< 10 ml/min or dialysis on day of transplant
Other illness
- Multi-organ transplant recipient, i.e., heart-lung or lung-liver
- HIV seropositive
- HCV antibody or HCV RNA positive
- Donor HCV NAT positive
- Known or suspected hypersensitivity to LET or acyclovir
- Child-Pugh Class C severe hepatic insufficiency
Other
- Pregnancy or expected to conceive while on LET and through at least 90 days following cessation of LET
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.