Clinical trial NCT05958186: A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
Official title: A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China
Keywords: Cytomegalovirus
Children
Adult
Liver transplantation
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-07-24
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Clinically significant CMV reactivation or CMV disease was observed within 12 months of transplantation
timeFrame: Within 22 months after liver transplantation
measure: End of follow-up survey
timeFrame: Within 22 months after liver transplantation
measure: Death
timeFrame: Within 22 months after liver transplantation
Secondary outcomes:
measure: Loss to follow-up survey
timeFrame: Within 22 months after liver transplantation
measure: Participants asked to withdraw
timeFrame: Within 22 months after liver transplantation
Other outcomes:
Locations:
Study officials:
References: