Hepatitis B Virus Infection After Liver Transplantation in Children

NCT03865966 | Unknown DMC

• 1 other identifier: 2019-24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B Infection

Outcome Measures

Primary Outcomes (2)

• The rate of occult hepatitis b virus infection

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

  3-5 years

• 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 Outcomes (1)

• The levels and changes of anti-HBs after liver transplantation

  3-5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End-stage liver disease requires liver transplantation.

You may qualify if:

• Patients with end-stage liver disease who require liver transplantation

You may not qualify if:

• Children without liver transplantation refer to children;
• Children who are unwilling to participate;

Sponsors & Collaborators

• Qiu Li: lead

Study Sites (1)

Chongqing Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and liver tissue specimens。

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Yao Zhao

  Chongqing Children's Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Zhao

CONTACT

+862363603083; Zhaoy@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: July 5, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 3-5 years

Locations

CN (1)