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RecruitingNCT03865966Updated Jul 8, 2019

Hepatitis B Virus Infection After Liver Transplantation in Children

An observational study in Hepatitis B Infection, sponsored by Qiu Li. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2019-07-08.

Sponsored by Qiu Li · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis B Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Qiu Li is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

End-stage liver disease requires liver transplantation.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Children without liver transplantation refer to children;
  • Children who are unwilling to participate;
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. The rate of occult hepatitis b virus infection

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

    Time frame: 3-5 years

  2. The rate of overt hepatitis b virus infection

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

    Time frame: 3-5 years

Secondary outcomes

  1. The levels and changes of anti-HBs after liver transplantation

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

    Time frame: 3-5 years

07

Study locations

1 of 1 sites recruiting
  • Chongqing Children's Hospital of Chongqing Medical University
    Chongqing, Chongqing 400014, China
    • Yao Zhao · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03865966
Lead sponsor
Qiu Li
Responsible party
Qiu Li (Principal Investigator, Children's Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Mar 7, 2019
Start date
Jul 5, 2019 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 8, 2019

Study contacts

Yao Zhao
Contact
Zhaoy@cqmu.edu.cn
+862363603083
Yao Zhao
principal investigator · Chongqing Children's Hospital of Chongqing Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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