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

NCT05958186 | Completed Results

• 1 other identifier: SHLTQC-6
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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

Keywords

Cytomegalovirus; Children; Adult; Liver transplantation

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Clinically Significant CMV Reactivation or CMV Disease

  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.

  Within 12 months after liver transplantation

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

  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.

  Within 12 months after liver transplantation

• All-Cause Mortality

  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.

  Within 12 months after liver transplantation

Secondary Outcomes (2)

• Number of Participants Lost to Follow-up

  Within 12 months after liver transplantation

• Participants Asked to Withdraw

  Within 12 months after liver transplantation

Study Arms (3)

Prophylaxis Strategy Cohort

Consecutive patients receiving universal antiviral prophylaxis as the standard-of- care CMV prevention strategy post-transplant.

Preemptive Strategy Cohort

Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.

No Prevention Strategy Cohort

Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lin Zhong: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum of recipients.

Limitations and Caveats

The observational design, while reflecting real-world practice, introduces potential for confounding despite multivariate adjustment. Variations in immunosuppression protocols and CMV monitoring techniques across centers, though reflecting clinical reality, may have influenced outcomes. Additionally, the lack of systematic assessment of antiviral resistance and detailed immunological parameters limits our ability to explore mechanistic explanations for the observed findings.

Results Point of Contact

• Title: LZhong
• Organization: Shanghai1st

q1-wt@163.com

+8617317371083

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 24, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2025-09

Locations

CN (1)