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Clinical Trial 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.


Clinical Trial Description

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NCT number NCT05958186
Study type Observational
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact Lin Zhong, professor
Phone 13917603139
Email zhonglin@medmail.com.cn
Status Not yet recruiting
Phase
Start date August 2023
Completion date August 2025