Trial Outcomes & Findings for Letermovir Use in Heart Transplant Recipients (NCT NCT04904614)
NCT ID: NCT04904614
Last Updated: 2025-07-29
Results Overview
We will count the number of patients with neutropenia seen over one year and calculate the proportion who become neutropenic. A comparison group of historic controls from a similar population is available for comparison. We know the control group has a 30% likelihood of becoming neutropenic at one year.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
12 months
Results posted on
2025-07-29
Participant Flow
Participants in the historical control arm were not considered enrolled in this study.
Participant milestones
| Measure |
Single Arm
Letermovir 480 mg daily for cytomegalovirus (CMV) prophylaxis
|
Historical Controls
Retrospectively collected historical controls who received valganciclovir for CMV prophylaxis; not enrolled in current study
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult heart transplant (HT) recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
204
|
|
Overall Study
COMPLETED
|
32
|
204
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Letermovir Use in Heart Transplant Recipients
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=32 Participants
Letermovir 480 mg daily for cmv prophylaxis
Letermovir: Open label trial of the licensed drug, letermovir, in a population of heart transplant recipients for which it is not yet licensed
|
Historical Controls
n=204 Participants
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult HT recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
These patients were NOT enrolled in current study.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 12 • n=5 Participants
|
53 years
STANDARD_DEVIATION 12 • n=7 Participants
|
53 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
204 participants
n=7 Participants
|
236 participants
n=5 Participants
|
|
CMV Donor IgG seropositive/Recipient IgG seronegative (CMV D+/R-)
|
19 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsWe will count the number of patients with neutropenia seen over one year and calculate the proportion who become neutropenic. A comparison group of historic controls from a similar population is available for comparison. We know the control group has a 30% likelihood of becoming neutropenic at one year.
Outcome measures
| Measure |
Single Arm
n=32 Participants
Letermovir 480 mg daily for cmv prophylaxis
|
Historical Controls
n=204 Participants
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult HT recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
These patients were NOT enrolled in current study.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
|---|---|---|
|
Proportion of Patients With Neutropenia Compared to Historical Controls
|
0 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of patients who develop CMV infection, comparison will be made to historic control group who were taking valganciclovir for CMV prophylaxis
Outcome measures
| Measure |
Single Arm
n=32 Participants
Letermovir 480 mg daily for cmv prophylaxis
|
Historical Controls
n=204 Participants
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult HT recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
These patients were NOT enrolled in current study.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
|---|---|---|
|
Rate of CMV Infection in Letermovir Recipients Compared to Historical Controls
|
11 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of patients who develop an opportunistic infection
Outcome measures
| Measure |
Single Arm
n=32 Participants
Letermovir 480 mg daily for cmv prophylaxis
|
Historical Controls
n=204 Participants
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult HT recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
These patients were NOT enrolled in current study.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
|---|---|---|
|
Rate of Opportunistic Infections in Letermovir Arm Compared to Historical Controls
|
3 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of patients with adverse events will be collected using a data questionnaire, and examination of lab data, need for subsequent hospitalization. There is no comparator group for this purely descriptive outcome.
Outcome measures
| Measure |
Single Arm
n=32 Participants
Letermovir 480 mg daily for cmv prophylaxis
|
Historical Controls
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult HT recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
These patients were NOT enrolled in current study.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
|---|---|---|
|
Tolerability and Compliance of Letermovir
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearComparison of Proportions
Outcome measures
| Measure |
Single Arm
n=32 Participants
Letermovir 480 mg daily for cmv prophylaxis
|
Historical Controls
n=204 Participants
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult HT recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
These patients were NOT enrolled in current study.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
|---|---|---|
|
Use of Granulocyte Colony Stimulation Factor (GCSF) in Letermovir Recipients Compared to Historical Controls
|
9 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: single time point measured within 2 weeks after completion of prophylaxis therapy, at either 3 months or 6 months, depending on duration of prophylaxisPopulation: 3 missing data
Single measurement of specific T-cell immune function to CMV. There is no comparator arm for this outcome because this test did not exist at time of historical controls. This is a measure of CMV specific T-cell immunity based on a commercial assay that yields one of 3 results: positive (CMV T-cell function is measured), indeterminate, negative (CMV T-cell function is not measured). A positive T-cell test is considered a better outcome.
Outcome measures
| Measure |
Single Arm
n=29 Participants
Letermovir 480 mg daily for cmv prophylaxis
|
Historical Controls
A total of 204 CMV D+/R- and CMV R+ patients on valganciclovir for CMV prophylaxis formed our historical control group of adult HT recipients at Tufts Medical Center from January 2004 to December 2017 who were followed for one-year post-HT for development of neutropenia, as well as infection, rejection, and survival.
These patients were NOT enrolled in current study.
Chow JKL, Ruthazer R, Boucher HW, Vest AR, DeNofrio DM, Snydman DR: Factors associated with neutropenia post heart transplantation. Transpl Infect Dis 2021;23:e13634.
|
|---|---|---|
|
Measure of CMV Specific T Cell Immunity in Letermovir Recipients
positive CMV T-cell test
|
20 Participants
|
—
|
|
Measure of CMV Specific T Cell Immunity in Letermovir Recipients
negative CMV T-cell test
|
4 Participants
|
—
|
|
Measure of CMV Specific T Cell Immunity in Letermovir Recipients
Indeterminate CMV T-cell test
|
5 Participants
|
—
|
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place