Hepatitis B Virus Infection After Liver Transplantation i... | NCT03865966

Studies
Hepatitis B Virus Infection After Liver Transplantation in Children

NCT03865966

Sponsor

Qiu Li

Status

Unknown status

Last Update Posted

Jul 8, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatitis B Infection

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2019Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 4, 2019

First Submission Date that Met QC Criteria

Mar 5, 2019

First Posted Date

Mar 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2019

Last Update Posted Date

Jul 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

End-stage liver disease requires liver transplantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yao Zhao	Contact	+862363603083		Zhaoy@cqmu.edu.cn

Overall Officials

Name	Affiliation	Role
Yao Zhao	Chongqing Children's Hospital of Chongqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chongqing Children's Hospital of Chongqing Medical University	Recruiting	Chongqing	Chongqing Municipality	400014	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

3-5 years

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided