Clincosm LogoSign in Get a demo

Hepatitis B Virus Infection After Liver Transplantation in Children

Sponsor
Qiu Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT03865966
Collaborator
(none)
100
Enrollment
1
Location
77.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

China is a highly prevalent area of hepatitis B virus（HBV） infection, with at least 75 million hepatitis B virus carriers, and 80% of primary hepatocellular carcinoma (HCC) is associated with chronic hepatitis B virus infection. Liver transplantation is currently the preferred method for end-stage liver disease such as biliary atresia and cirrhosis in children. In recent years, children's liver transplantation has developed rapidly and the number of developments has increased significantly. If there is chronic hepatitis B virus infection in the donor liver, it may cause HBV transmission, or the patient may have a low-load occult hepatitis B virus infection, and after immunosuppressive treatment, it may lead to hepatitis B virus infection after surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical Follow-up Study on Hepatitis B Virus Infection After Liver Transplantation in Children
    Anticipated Study Start Date :
    Jul 5, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. The rate of occult hepatitis b virus infection [3-5 years]

      Clinical follow-up testing for occult HBV infection after liver transplantation in children

    2. The rate of overt hepatitis b virus infection [3-5 years]

      Clinical follow-up testing for overt HBV infection after liver transplantation in children

    Secondary Outcome Measures

    1. The levels and changes of anti-HBs after liver transplantation [3-5 years]

      Clinical follow-up testing for HBV seromarkers after liver transplantation in children

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with end-stage liver disease who require liver transplantation
    Exclusion Criteria:

    • Children without liver transplantation refer to children;

    • Children who are unwilling to participate;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chongqing Children's Hospital of Chongqing Medical University Chongqing Chongqing China 400014

    Sponsors and Collaborators

    • Qiu Li

    Investigators

    • Principal Investigator: Yao Zhao, Chongqing Children's Hospital of Chongqing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qiu Li, Principal Investigator, Children's Hospital of Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT03865966
    Other Study ID Numbers:
    • 2019-24
    First Posted:
    Mar 7, 2019
    Last Update Posted:
    Jul 8, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Hepatitis A
    Hepatitis B
    Virus Diseases
    Herpesviridae Infections
    Hepatitis

    Study Results

    No Results Posted as of Jul 8, 2019