Hepatitis B InfectionNCT03865966
Hepatitis B Virus Infection After Liver Transplantation in Children
An observational study of Hepatitis B Infection, run by Qiu Li at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Infection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: End-stage liver disease requires liver transplantation.
Who may be able to join
- Patients with end-stage liver disease who require liver transplantation
Who cannot join
- Children without liver transplantation refer to children;
- Children who are unwilling to participate;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Yao Zhao
About this study
Official title: Clinical Follow-up Study on Hepatitis B Virus Infection After Liver Transplantation in Children
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
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of occult hepatitis b virus infection
Clinical follow-up testing for occult HBV infection after liver transplantation in children
Measured: 3-5 years
The rate of overt hepatitis b virus infection
Clinical follow-up testing for overt HBV infection after liver transplantation in children
Measured: 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
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start5 Jul 2019 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiu Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiu Li, Children's Hospital of Chongqing Medical University
- Investigators
- Yao Zhao, Principal investigator, Chongqing Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865966
- Sponsor's protocol ID
- 2019-24
- Status last verified
- Jul 2019
- First submitted
- 4 Mar 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up Study on Hepatitis B Virus Infection After Liver Transplantation in Children
- ClinicalTrials.gov ID
- NCT03865966
- Acronym / sponsor ID
- 2019-24
- Conditions
- Hepatitis B Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qiu LiUniversity, hospital or other
- Study start
- 5 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- End-stage liver disease requires liver transplantation.
Key inclusion criteria (1 listed)
- Patients with end-stage liver disease who require liver transplantation
Key exclusion criteria (2 listed)
- Children without liver transplantation refer to children;
- Children who are unwilling to participate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
The rate of occult hepatitis b virus infection
Time frame: 3-5 years
Clinical follow-up testing for occult HBV infection after liver transplantation in children
The rate of overt hepatitis b virus infection
Time frame: 3-5 years
Clinical follow-up testing for overt HBV infection after liver transplantation in children
1 secondary outcome
The levels and changes of anti-HBs after liver transplantation
Time frame: 3-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Zhao principal investigator
Chongqing Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Infection, run by Qiu Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Zhao (+862363603083, Zhaoy@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of occult hepatitis b virus infection (time frame: 3-5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.