A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
July 21, 2023 updated by: Lin Zhong
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.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Zhong, professor
- Phone Number: 13917603139
- Email: zhonglin@medmail.com.cn
Study Contact Backup
- Name: Shubin Zhang, postgraduate students
- Phone Number: 17354608852
- Email: 1294535821@qq.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Children group
Ages≤18
|
|
Adults group
Ages>18
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinically significant CMV reactivation or CMV disease was observed within 12 months of transplantation
Time Frame: Within 22 months after liver transplantation
|
1. CMV reactivation: CMV-lgG is positive and any one of CMV-lgM, pp65 and CMV-DNA is positive is called CMV reactivation.
|
Within 22 months after liver transplantation
|
|
End of follow-up survey
Time Frame: Within 22 months after liver transplantation
|
We will perform a follow-up for 22 months if participant is alive and does not observed CMV reactivation.
|
Within 22 months after liver transplantation
|
|
Death
Time Frame: Within 22 months after liver transplantation
|
The participant died
|
Within 22 months after liver transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loss to follow-up survey
Time Frame: Within 22 months after liver transplantation
|
During follow-up, if we can not connect with participant, we regard this event as loss to follow-up.
|
Within 22 months after liver transplantation
|
|
Participants asked to withdraw
Time Frame: Within 22 months after liver transplantation
|
During follow-up, participants refuse to keep this study within 22 months after liver transplantation
|
Within 22 months after liver transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2023
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
July 12, 2023
First Submitted That Met QC Criteria
July 21, 2023
First Posted (Estimated)
July 24, 2023
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHLTQC-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.