CompletedNot Applicable

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

China800 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Clinically Significant CMV Reactivation or CMV Disease

Timeframe: Within 12 months after liver transplantation

Number of Participants Who Completed the 12-Month Follow-up

Timeframe: Within 12 months after liver transplantation

All-Cause Mortality

Timeframe: Within 12 months after liver transplantation

Trial details

NCT IDNCT05958186

SponsorLin Zhong

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-01

Results submitted2025-09-13

View on ClinicalTrials.gov More Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Clinically Significant CMV Reactivation or CMV Disease

Timeframe: Within 12 months after liver transplantation

Number of Participants Who Completed the 12-Month Follow-up

Timeframe: Within 12 months after liver transplantation

All-Cause Mortality

Timeframe: Within 12 months after liver transplantation