Trial Outcomes & Findings for A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China (NCT NCT05958186)
NCT ID: NCT05958186
Last Updated: 2026-04-13
Results Overview
Clinically significant CMV reactivation was defined as a positive CMV-DNA PCR or pp65 antigenemia test in the context of clinical symptoms attributable to CMV. CMV disease was defined as evidence of CMV infection with documented end-organ disease (e.g., CMV hepatitis, colitis, pneumonitis) according to established international guidelines.
COMPLETED
800 participants
Within 12 months after liver transplantation
2026-04-13
Participant Flow
This investigation employed a prospective, observational cohort design conducted across six high-volume liver transplant centers in China: Shanghai General Hospital, Ruijin Hospital, The First Affiliated Hospital of Jilin University, The First Affiliated Hospital of Zhengzhou University, West China Hospital, and Tianjin First Central Hospital. Recruitment occurred between August 2023 and June 2024, with a 12-month follow-up period for each participant concluding in June 2025.
A total of 1020 consecutive liver transplant recipients were screened for eligibility. Of these, 220 patients did not meet the inclusion criteria or declined to participate. Therefore, 800 patients were enrolled and constituted the study cohort
Participant milestones
| Measure |
Prophylaxis Strategy Cohort
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
|---|---|---|---|
|
Overall Study
STARTED
|
320
|
310
|
170
|
|
Overall Study
COMPLETED
|
315
|
305
|
166
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
Baseline characteristics by cohort
| Measure |
Prophylaxis Strategy Cohort
n=320 Participants
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
n=310 Participants
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
n=170 Participants
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
Total
n=800 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.5 year
STANDARD_DEVIATION 18.2 • n=193 Participants
|
43.1 year
STANDARD_DEVIATION 19.5 • n=193 Participants
|
39.8 year
STANDARD_DEVIATION 17.6 • n=386 Participants
|
41.8 year
STANDARD_DEVIATION 18.6 • n=112 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=193 Participants
|
112 Participants
n=193 Participants
|
65 Participants
n=386 Participants
|
305 Participants
n=112 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=193 Participants
|
198 Participants
n=193 Participants
|
105 Participants
n=386 Participants
|
495 Participants
n=112 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Asian
|
320 Participants
n=193 Participants
|
310 Participants
n=193 Participants
|
170 Participants
n=386 Participants
|
800 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
MELD score at transplant
|
22.5 units on a scale
n=193 Participants
|
21 units on a scale
n=193 Participants
|
23 units on a scale
n=386 Participants
|
22 units on a scale
n=112 Participants
|
PRIMARY outcome
Timeframe: Within 12 months after liver transplantationClinically significant CMV reactivation was defined as a positive CMV-DNA PCR or pp65 antigenemia test in the context of clinical symptoms attributable to CMV. CMV disease was defined as evidence of CMV infection with documented end-organ disease (e.g., CMV hepatitis, colitis, pneumonitis) according to established international guidelines.
Outcome measures
| Measure |
Prophylaxis Strategy Cohort
n=320 Participants
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
n=310 Participants
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
n=170 Participants
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant CMV Reactivation or CMV Disease
CMV Infection
|
62 Participants
|
89 Participants
|
78 Participants
|
|
Number of Participants With Clinically Significant CMV Reactivation or CMV Disease
CMV Disease
|
32 Participants
|
58 Participants
|
56 Participants
|
|
Number of Participants With Clinically Significant CMV Reactivation or CMV Disease
Late-onset CMV
|
12 Participants
|
31 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: Within 12 months after liver transplantationPopulation: 315 participants completed follow-up in prophylaxis group, 305 participants completed follow-up in preemptive group, and 166 participants completed follow-up in non-prevention group.
Participants were considered to have completed the study if they were alive and did not experience CMV reactivation requiring study closure, and provided data through the 12-month post-transplant visit.
Outcome measures
| Measure |
Prophylaxis Strategy Cohort
n=320 Participants
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
n=310 Participants
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
n=170 Participants
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
|---|---|---|---|
|
Number of Participants Who Completed the 12-Month Follow-up
|
315 Participants
|
305 Participants
|
166 Participants
|
PRIMARY outcome
Timeframe: Within 12 months after liver transplantationThe occurrence of death from any cause within 12 months post-transplantation. As this was an observational study, mortality was assessed as an efficacy outcome (to calculate survival probability) rather than a solicited adverse event. Deaths were identified through scheduled study follow-ups, review of medical records, and when necessary, verification with civil registries.
Outcome measures
| Measure |
Prophylaxis Strategy Cohort
n=320 Participants
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
n=310 Participants
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
n=170 Participants
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
|---|---|---|---|
|
All-Cause Mortality
|
16 Participants
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Within 12 months after liver transplantationPopulation: Five participants lost to follow-up in prophylaxis group, five participants lost to follow-up in preemptive group, and four participants lost to follow-up in non-prevention group.
Participants were considered lost to follow-up if they could not be contacted for scheduled study visits or assessments despite multiple attempts, and no outcome data could be obtained after their last contact.
Outcome measures
| Measure |
Prophylaxis Strategy Cohort
n=320 Participants
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
n=310 Participants
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
n=170 Participants
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
|---|---|---|---|
|
Number of Participants Lost to Follow-up
|
5 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 12 months after liver transplantationPopulation: Non of participants asked to withdraw.
During follow-up, participants refuse to keep this study within 12 months after liver transplantation
Outcome measures
| Measure |
Prophylaxis Strategy Cohort
n=320 Participants
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
n=310 Participants
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
n=170 Participants
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
|---|---|---|---|
|
Participants Asked to Withdraw
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Prophylaxis Strategy Cohort
Preemptive Strategy Cohort
No Prevention Strategy Cohort
Serious adverse events
| Measure |
Prophylaxis Strategy Cohort
n=320 participants at risk
Consecutive patients receiving universal antiviral prophylaxis as the standard-of-care CMV prevention strategy post-transplant.
|
Preemptive Strategy Cohort
n=310 participants at risk
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
|
No Prevention Strategy Cohort
n=170 participants at risk
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
|
|---|---|---|---|
|
General disorders
Serious adverse events leading to hospitalization or graft loss
|
17.2%
55/320 • Number of events 55 • From enrollment until end of follow-up, up to 12 months
As an observational study, the protocol did not mandate solicitation of all adverse events. However, mortality (all-cause death) and serious adverse events leading to hospitalization or graft loss were actively collected as part of the study outcomes. Other non-serious adverse events were not systematically collected.
|
19.4%
60/310 • Number of events 60 • From enrollment until end of follow-up, up to 12 months
As an observational study, the protocol did not mandate solicitation of all adverse events. However, mortality (all-cause death) and serious adverse events leading to hospitalization or graft loss were actively collected as part of the study outcomes. Other non-serious adverse events were not systematically collected.
|
23.5%
40/170 • Number of events 40 • From enrollment until end of follow-up, up to 12 months
As an observational study, the protocol did not mandate solicitation of all adverse events. However, mortality (all-cause death) and serious adverse events leading to hospitalization or graft loss were actively collected as part of the study outcomes. Other non-serious adverse events were not systematically collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place