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

NCT ID: NCT05958186

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2025-08-31

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Children group

Ages≤18

No interventions assigned to this group

Adults group

Ages\>18

No interventions assigned to this group

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Lin Zhong

OTHER

Sponsor Role: lead

Responsible Party

Lin Zhong

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Lin Zhong, professor

Role: CONTACT

zhonglin@medmail.com.cn

13917603139

Shubin Zhang, postgraduate students

Role: CONTACT

1294535821@qq.com

17354608852

Other Identifiers

SHLTQC-6

Identifier Type: -

Identifier Source: org_study_id