Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in ChinaNCT05958186

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

An observational study of Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China, run by Lin Zhong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China
How many people: 800 participants
Where: 1 siteChina
Study dates: 1 Aug 2023to 1 Aug 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai General Hospital
Shanghai

Other trials in China

About this study

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05958186
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Within 12 months after liver transplantation

Secondary outcomes (2)

Number of Participants Lost to Follow-up
Participants were considered lost to follow-up if they could not be contacted for scheduled study visits or assessments despite multiple attempts, and no outcome data could be obtained after their last contact.
Measured: Within 12 months after liver transplantation
Participants Asked to Withdraw
During follow-up, participants refuse to keep this study within 12 months after liver transplantation
Measured: Within 12 months after liver transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20231 Aug 2025

First posted24 Jul 2023
Study start1 Aug 2023
Primary completion1 Jun 2025
Study completion1 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in ChinaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 800 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05958186
Sponsor's protocol ID: SHLTQC-6
Status last verified: Sep 2025
First submitted: 12 Jul 2023
Last updated: 13 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
ClinicalTrials.gov ID: NCT05958186
Acronym / sponsor ID: SHLTQC-6
Conditions: Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China
Keywords: Cytomegalovirus, Children, Adult, Liver transplantation
Study type: Observational
Recruitment status: Completed
Enrolment: 800 participants (actual)
Lead sponsor: Lin ZhongUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 1 Aug 2023 (actual)
Primary completion: 1 Jun 2025 (actual)
Study completion: 1 Aug 2025 (actual)
First posted: 24 Jul 2023 (actual)
Results: Posted 13 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Clinically Significant CMV Reactivation or CMV Disease
Time frame: Within 12 months after liver transplantation
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.
Number of Participants Who Completed the 12-Month Follow-up
Time frame: Within 12 months after liver transplantation
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.
All-Cause Mortality
Time frame: Within 12 months after liver transplantation
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.

2 secondary outcomes

Number of Participants Lost to Follow-up
Time frame: Within 12 months after liver transplantation
Participants Asked to Withdraw
Time frame: Within 12 months after liver transplantation

Results and safety

Results posted to the registry on 13 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prophylaxis Strategy Cohort	320	315
Preemptive Strategy Cohort	310	305
No Prevention Strategy Cohort	170	166

Primary outcome: Number of Participants With Clinically Significant CMV Reactivation or CMV Disease

Time frame: Within 12 months after liver transplantation. Count of participants. Unit: Participants

Measure	Prophylaxis Strategy Cohort n = 320	Preemptive Strategy Cohort n = 310	No Prevention Strategy Cohort n = 170
CMV Infection	62	89	78
CMV Disease	32	58	56
Late-onset CMV	12	31	44

Primary outcome: Number of Participants Who Completed the 12-Month Follow-up

Time frame: Within 12 months after liver transplantation. Count of participants. Unit: Participants

Measure	Prophylaxis Strategy Cohort n = 320	Preemptive Strategy Cohort n = 310	No Prevention Strategy Cohort n = 170
Value	315	305	166

Population analysed: 315 participants completed follow-up in prophylaxis group, 305 participants completed follow-up in preemptive group, and 166 participants completed follow-up in non-prevention group.

Primary outcome: All-Cause Mortality

Time frame: Within 12 months after liver transplantation. Count of participants. Unit: Participants

Measure	Prophylaxis Strategy Cohort n = 320	Preemptive Strategy Cohort n = 310	No Prevention Strategy Cohort n = 170
Value	16	16	13

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prophylaxis Strategy Cohort	55 of 320 (17.2%)	0 of 0	16 of 320
Preemptive Strategy Cohort	60 of 310 (19.4%)	0 of 0	16 of 310
No Prevention Strategy Cohort	40 of 170 (23.5%)	0 of 0	13 of 170

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China, run by Lin Zhong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant CMV Reactivation or CMV Disease (time frame: Within 12 months after liver transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05958186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.