Lung TransplantPhase 2NCT05041426

Letermovir for CMV Prevention After Lung Transplantation

A Phase 2 study testing Letermovir and Valganciclovir in people with Lung Transplant and CMV, run by Fernanda P Silveira, MD, MS at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Lung Transplant, CMV
What is being tested?: Letermovir and Valganciclovir
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 6 Dec 2021to 3 Mar 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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 following cessation of LET

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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

Read the detailed description

Approximately 30 patients with IPF listed for lung transplantation will be enrolled and 15 are expected to undergo lung transplantation during the study period and receive the intervention. Patients who are CMV seropositive will receive letermovir for 6 months, patients who are CMV seronegative and receive lungs from a CMV seropositive donor (CMV D+/R-) will receive letermovir for 12 months. All patients will be followed for 12 weeks after completion of letermovir for the occurrence of CMV infection or disease after prophylaxis.

Historical controls will be LTRs for IPF from 2010-2019 who are CMV R+ or CMV D+/R- (donor positive/recipient negative). CMV prophylaxis in the historical controls was with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-. Patients will be matched for CMV serostatus, induction immunosuppression, age, and telomere length.

Conditions: Lung Transplant, CMV
Being tested: Letermovir, Valganciclovir
Keywords: Lung transplant, CMV, Letermovir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LetermovirDrug
Also called Prevymis
Participants who are CMV R+ will receive LET prophylaxis for 6 months, and participants who are CMV D+/R- will receive LET prophylaxis for 12 months. The duration of prophylaxis is per current standard of care. LET will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If LET is co-administered with cyclosporin A (CsA), the dosage of LET should be decreased to 240 mg once daily. All patients will be followed for 12 weeks after completion of LET for the occurrence of CMV infection or disease after prophylaxis. Participants on this protocol will receive acyclovir 400 mg orally BID for the duration of LET therapy for herpes simplex virus and varicella zoster virus prophylaxis.
ValganciclovirDrug
Historical controls will have received CMV prophylaxis with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.

Study groups in NCT05041426
Study group	Role	What they receive
Letermovir	Experimental	Participants who are CMV seropositive (CMV R+) will receive letermovir prophylaxis for 6 months, and participants who are CMV donor seropositive/recipient seronegative (CMV D+/R-) will receive letermovir prophylaxis for 12 months. Letermovir will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If letermovir is co-administered with cyclosporine A, the dosage of letermovir will be decreased to 240 mg once daily. Receives: Drug: Letermovir
Valganciclovir	Active comparator	Historical controls will be lung transplant recipients for idiopathic pulmonary fibrosis from 2010-2019 who are CMV R+ or CMV D+/R-. CMV prophylaxis in the historical controls was with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-. Receives: Drug: Valganciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of CMV Infection or Disease During Prophylaxis
Number of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease during letermovir prophylaxis.
Measured: 6-12 months post-transplant
Occurrence of CMV Infection or Disease in the 3 Months Following Completion of Prophylaxis
Number of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease in the 3 months following completion of prophylaxis with letermovir.
Measured: 12 weeks after completion of letermovir

Secondary outcomes (2)

Discontinuation Events
Discontinuation of letermovir due to adverse events or intolerability
Measured: 6-12 months
Occurrence of Leukopenia or Neutropenia While on Prophylaxis
Number of participants who develop any of the following while receiving letermovir: total WBC count ≤ 3,500 cells/mL or absolute neutrophil count ≤ 1,000 cells/mL.
Measured: 6-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 20213 Mar 2025

First posted13 Sep 2021
Study start6 Dec 2021
Primary completion3 Mar 2025
Study completion3 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung TransplantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Interventional, open-label, single center, pilot study with historical controls
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05041426
Sponsor's protocol ID: STUDY21040074
Status last verified: Mar 2026
First submitted: 20 Apr 2021
Last updated: 9 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: We do not plan to share individual participant data outside of our investigative team. Aggregate data will be shared in publications as appropriate.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke

All Lung Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05041426
Acronym / sponsor ID: STUDY21040074
Conditions: Lung Transplant, CMV
Keywords: Lung transplant, CMV, Letermovir
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Fernanda P Silveira, MD, MSUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 6 Dec 2021 (actual)
Primary completion: 3 Mar 2025 (actual)
Study completion: 3 Mar 2025 (actual)
First posted: 13 Sep 2021 (actual)
Results: Posted 9 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Interventional, open-label, single center, pilot study with historical controls

Arm	Type	Receives
Letermovir	Experimental	Drug: LetermovirParticipants who are CMV seropositive (CMV R+) will receive letermovir prophylaxis for 6 months, and participants who are CMV donor seropositive/recipient seronegative (CMV D+/R-) will receive letermovir prophylaxis for 12 months. Letermovir will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If letermovir is co-administered with cyclosporine A, the dosage of letermovir will be decreased to 240 mg once daily.
Valganciclovir	Active comparator	Drug: ValganciclovirHistorical controls will be lung transplant recipients for idiopathic pulmonary fibrosis from 2010-2019 who are CMV R+ or CMV D+/R-. CMV prophylaxis in the historical controls was with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LetermovirAlso: PrevymisParticipants who are CMV R+ will receive LET prophylaxis for 6 months, and participants who are CMV D+/R- will receive LET prophylaxis for 12 months. The duration of prophylaxis is per current standard of care. LET will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If LET is co-administered with cyclosporin A (CsA), the dosage of LET should be decreased to 240 mg once daily. All patients will be followed for 12 weeks after completion of LET for the occurrence of CMV infection or disease after prophylaxis. Participants on this protocol will receive acyclovir 400 mg orally BID for the duration of LET therapy for herpes simplex virus and varicella zoster virus prophylaxis.	Drug	Letermovir
ValganciclovirHistorical controls will have received CMV prophylaxis with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.	Drug	Valganciclovir

Primary outcome

Occurrence of CMV Infection or Disease During Prophylaxis
Time frame: 6-12 months post-transplant
Number of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease during letermovir prophylaxis.
Occurrence of CMV Infection or Disease in the 3 Months Following Completion of Prophylaxis
Time frame: 12 weeks after completion of letermovir
Number of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease in the 3 months following completion of prophylaxis with letermovir.

2 secondary outcomes

Discontinuation Events
Time frame: 6-12 months
Occurrence of Leukopenia or Neutropenia While on Prophylaxis
Time frame: 6-12 months

Results and safety

Results posted to the registry on 9 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Letermovir	15	12

Primary outcome: Occurrence of CMV Infection or Disease During Prophylaxis

Time frame: 6-12 months post-transplant. Count of participants. Unit: Participants

Measure	Letermovir n = 15
CMV donor positive recipient negative	0

Primary outcome: Occurrence of CMV Infection or Disease in the 3 Months Following Completion of Prophylaxis

Time frame: 12 weeks after completion of letermovir. Count of participants. Unit: Participants

Measure	Letermovir n = 13
Value	7

Population analysed: Two participants could not be analyzed for this outcome due to death and participant's withdrawal from the study. An additional participant had early discontinuation of letermovir due to inability to take oral medication at the time of discharge but continued to have CMV PCRs monitored and was included in this analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From transplant until discontinuation of letermovir prophylaxis, up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Letermovir	4 of 15 (26.7%)	2 of 15 (13.3%)	2 of 15

Limitations and caveats (from the sponsor): The sample size of 15 participants - appropriate for a pilot study and consistent with the study's pre-specified goal - limits statistical power. The open label, single center, single arm design without a concurrent control group precludes definitive conclusions about the efficacy or safety of letermovir in lung transplant recipients relative to valganciclovir.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. We do not plan to share individual participant data outside of our investigative team. Aggregate data will be shared in publications as appropriate.

Related trials for Lung Transplant

RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fernanda Silveira principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letermovir and Valganciclovir in people with Lung Transplant and CMV, run by Fernanda P Silveira, MD, MS at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of CMV Infection or Disease During Prophylaxis (time frame: 6-12 months post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.