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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05958186
Recruitment Status : Not yet recruiting
First Posted : July 24, 2023
Last Update Posted : July 24, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Lin Zhong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Description
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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.

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

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Children group
Ages≤18
Adults group
Ages>18


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Death [ Time Frame: Within 22 months after liver transplantation ]
    The participant died


Secondary Outcome Measures :
  1. 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.

  2. 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


Biospecimen Retention:   Samples With DNA
Plasma and serum of recipients.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05958186


Contacts
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Contact: Lin Zhong, professor 13917603139 zhonglin@medmail.com.cn
Contact: Shubin Zhang, postgraduate students 17354608852 1294535821@qq.com

Sponsors and Collaborators
Lin Zhong
Merck Sharp & Dohme LLC
More Information
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Responsible Party: Lin Zhong, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT05958186    
Other Study ID Numbers: SHLTQC-6
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: July 24, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lin Zhong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Cytomegalovirus
Children
Adult
Liver transplantation
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections