Completed

NCT Number: NCT05958186

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of Participants With Clinically Significant CMV Reactivation or CMV Disease

Time frame: 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

Time frame: 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

Time frame: 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 outcomes

Number of Participants Lost to Follow-up

Time frame: 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

Time frame: Within 12 months after liver transplantation

During follow-up, participants refuse to keep this study within 12 months after liver transplantation

Sponsors and collaborators

Lead sponsor

Lin Zhong

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jul 24, 2023
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.