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
• Status: Recruiting
• 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
• 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;

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Infection
• Herpesviridae Infections
• Infection
• Virus Diseases

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