Trial Outcomes & Findings for Letermovir for CMV Prevention After Lung Transplantation (NCT NCT05041426)
NCT ID: NCT05041426
Last Updated: 2026-04-09
Results Overview
Number of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease during letermovir prophylaxis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
6-12 months post-transplant
Results posted on
2026-04-09
Participant Flow
Patients with idiopathic pulmonary fibrosis who are active on the lung transplant or within the first 72 hours post-transplant could be enrolled.
The initial intent was to compare the letermovir group to historical controls from a separate cohort, who received valganciclovir prophylaxis; however, we did not have access to this data.
Participant milestones
| Measure |
Letermovir
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label 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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Letermovir
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label 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.
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|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Inability to take oral medications at hospital discharge
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Letermovir
n=15 Participants
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.
|
|---|---|
|
Age, Continuous
|
62 Years
n=15 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
|
Bilateral lung transplant
|
15 Participants
n=15 Participants
|
|
CMV serostatus
CMV seropositive
|
9 Participants
n=15 Participants
|
|
CMV serostatus
CMV Donor Positive Recipient Negative
|
6 Participants
n=15 Participants
|
|
Induction
Basiliximab
|
13 Participants
n=15 Participants
|
|
Induction
Thymoglobulin
|
1 Participants
n=15 Participants
|
|
Induction
Alemtuzumab
|
1 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 6-12 months post-transplantNumber of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease during letermovir prophylaxis.
Outcome measures
| Measure |
Letermovir
n=15 Participants
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label 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.
|
|---|---|
|
Occurrence of CMV Infection or Disease During Prophylaxis
CMV donor positive recipient negative
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after completion of letermovirPopulation: 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.
Number of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease in the 3 months following completion of prophylaxis with letermovir.
Outcome measures
| Measure |
Letermovir
n=13 Participants
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label 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.
|
|---|---|
|
Occurrence of CMV Infection or Disease in the 3 Months Following Completion of Prophylaxis
|
7 Participants
|
SECONDARY outcome
Timeframe: 6-12 monthsDiscontinuation of letermovir due to adverse events or intolerability
Outcome measures
| Measure |
Letermovir
n=15 Participants
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label 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.
|
|---|---|
|
Discontinuation Events
|
0 Participants
|
SECONDARY outcome
Timeframe: 6-12 monthsNumber 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.
Outcome measures
| Measure |
Letermovir
n=15 Participants
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label 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.
|
|---|---|
|
Occurrence of Leukopenia or Neutropenia While on Prophylaxis
|
2 Participants
|
Adverse Events
Letermovir
Serious events: 4 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Letermovir
n=15 participants at risk
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label letermovir prophylaxis for 12 months.
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|---|---|
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Nervous system disorders
Anoxic brain injury
|
6.7%
1/15 • From transplant until discontinuation of letermovir prophylaxis, up to 1 year
The patient population under study is complex. For this study, AEs will be collected only if protocol-stipulated, study related or unexpected. Reportable SAEs for this study will be adverse events that are serious and unexpected, i.e., not expected to occur with a reasonable frequency in the typical course of a patient following lung transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic respiratory failure
|
6.7%
1/15 • From transplant until discontinuation of letermovir prophylaxis, up to 1 year
The patient population under study is complex. For this study, AEs will be collected only if protocol-stipulated, study related or unexpected. Reportable SAEs for this study will be adverse events that are serious and unexpected, i.e., not expected to occur with a reasonable frequency in the typical course of a patient following lung transplant.
|
|
Gastrointestinal disorders
Abdominal pain with increased liver enzymes
|
6.7%
1/15 • From transplant until discontinuation of letermovir prophylaxis, up to 1 year
The patient population under study is complex. For this study, AEs will be collected only if protocol-stipulated, study related or unexpected. Reportable SAEs for this study will be adverse events that are serious and unexpected, i.e., not expected to occur with a reasonable frequency in the typical course of a patient following lung transplant.
|
|
Gastrointestinal disorders
Acute diverticulitis
|
6.7%
1/15 • From transplant until discontinuation of letermovir prophylaxis, up to 1 year
The patient population under study is complex. For this study, AEs will be collected only if protocol-stipulated, study related or unexpected. Reportable SAEs for this study will be adverse events that are serious and unexpected, i.e., not expected to occur with a reasonable frequency in the typical course of a patient following lung transplant.
|
Other adverse events
| Measure |
Letermovir
n=15 participants at risk
CMV seropositive (CMV R+) participants: open label letermovir prophylaxis for 6 months.
CMV donor seropositive/recipient seronegative (CMV D+/R-) participants: open label letermovir prophylaxis for 12 months.
|
|---|---|
|
Blood and lymphatic system disorders
White blood cell count less than 3,500
|
13.3%
2/15 • From transplant until discontinuation of letermovir prophylaxis, up to 1 year
The patient population under study is complex. For this study, AEs will be collected only if protocol-stipulated, study related or unexpected. Reportable SAEs for this study will be adverse events that are serious and unexpected, i.e., not expected to occur with a reasonable frequency in the typical course of a patient following lung transplant.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place