N/A
N=800
A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China
Bottom Line
View on ClinicalTrials.gov: NCT05958186 ↗Enrolled (actual)
800
Serious AEs
19.4%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants With Clinically Significant CMV Reactivation or CMV Disease — 62; 89; 78; 32 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Lin Zhong
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant CMV Reactivation or CMV Disease |
62; 89; 78; 32; 58; 56 | — |
| PRIMARY Number of Participants Who Completed the 12-Month Follow-up |
315; 305; 166 | — |
| PRIMARY All-Cause Mortality |
16; 16; 13 | — |
| SECONDARY Number of Participants Lost to Follow-up |
5; 5; 4 | — |
| SECONDARY Participants Asked to Withdraw |
0; 0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05958186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.