A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China

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.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The participates had received their first orthotopic liver transplantation within 10 days prior. And there are no gender restrictions. The number of participants are 800.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinically Significant CMV Reactivation or CMV Disease	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.	Within 12 months after liver transplantation
Number of Participants Who Completed the 12-Month Follow-up	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.	Within 12 months after liver transplantation
All-Cause Mortality	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.	Within 12 months after liver transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Lost to Follow-up	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.	Within 12 months after liver transplantation
Participants Asked to Withdraw	During follow-up, participants refuse to keep this study within 12 months after liver transplantation	Within 12 months after liver transplantation

Collaborators and Investigators

• Sponsor: Lin Zhong
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Liver transplantation; Children; Adult; Cytomegalovirus
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: SHLTQC-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No