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NCT03865966 Clinical Trial

Hepatitis B Virus Infection After Liver Transplantation in Children

Hepatitis B Infection Clinical Trial

Official title:
Clinical Follow-up Study on Hepatitis B Virus Infection After Liver Transplantation in Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03865966
Other study ID # 2019-24
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 5, 2019
Est. completion date December 31, 2025

Study information
Verified date July 2019
Source Children's Hospital of Chongqing Medical University
Contact Yao Zhao
Phone +862363603083
Email Zhaoy@cqmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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;

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Chongqing Children's Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)
Lead Sponsor Collaborator
Qiu Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The rate of occult hepatitis b virus infection Clinical follow-up testing for occult HBV infection after liver transplantation in children 3-5 years
Primary The rate of overt hepatitis b virus infection Clinical follow-up testing for overt HBV infection after liver transplantation in children 3-5 years
Secondary The levels and changes of anti-HBs after liver transplantation Clinical follow-up testing for HBV seromarkers after liver transplantation in children 3-5 years
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