Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China
Conditions
Keywords
Cytomegalovirus, Children, Adult, Liver transplantation
Brief summary
The goal of this observational study is to learn about cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in China. The main questions it aims to answer are: * The incidence of Cytomegalovirus (CMV) Infections (including clinical significant CMV reactivations and CMV Diseases) among children and adults Liver transplantation patients in China * All-cause Mortality (Survival probability at 1 year) * Incidence of Allograft Rejection. Number of subjects with allograft rejection * Graft Loss. Incidence of graft loss (re-transplantation) * Late-onset CMV Disease. Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee * Bacterial Infections. Incidence of bacterial opportunistic infections * Major Fungal Infections. Opportunistic fungal infections * Major Non-CMV Viral Infections. Incidence of non-CMV viral infections We will collect demographic data of participants. All recipients and donors underwent preoperative testing for CMV pp65 antigenemia, plasma CMV DNA, and serum CMV antibody. All the recipients were followed up in a liver transplant follow-up clinic twice weekly for a month after discharge from hospital. After that, patients were followed up weekly for 3 months, fortnightly for 6 months, and monthly for 12 months.
Interventions
None listed
Sponsors
Lin Zhong
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior. * Children group: Age ≤18yeas； * Adults group: Age \>18yeas； * Willingness to participate in the study * Ability to understand information material * Written informed consent
Exclusion criteria
* Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process). * Participation in another investigational agent trial * Be undergoing multi organ transplant or have undergone prior organ transplant. Have expected life expectancy of less than 72 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant CMV Reactivation or CMV Disease | Within 12 months after liver transplantation | 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. |
| Number of Participants Who Completed the 12-Month Follow-up | Within 12 months after liver transplantation | 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. |
| All-Cause Mortality | Within 12 months after liver transplantation | The 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Lost to Follow-up | Within 12 months after liver transplantation | 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. |
| Participants Asked to Withdraw | Within 12 months after liver transplantation | During follow-up, participants refuse to keep this study within 12 months after liver transplantation |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.5 year STANDARD_DEVIATION 18.2 |
| MELD score at transplant | 21 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 310 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 305 Participants |
| Sex: Female, Male Male | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 16 / 320 | 16 / 310 | 13 / 170 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 55 / 320 | 60 / 310 | 40 / 170 |
Outcome results
None listed