Epidemiological Survey of Hepatitis D Virus Infection in... | NCT04483518

Studies
Epidemiological Survey of Hepatitis D Virus Infection in China

NCT04483518

Sponsor

The First Hospital of Jilin University

Status

Completed

Last Update Posted

Jul 23, 2020Actual

Enrollment

5,000Actual

Phase

Not provided

Conditions

Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People

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 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2019Actual

Primary Completion Date

Jul 7, 2020Actual

Completion Date

Jul 7, 2020Actual

First Submitted Date

Jul 20, 2020

First Submission Date that Met QC Criteria

Jul 20, 2020

First Posted Date

Jul 23, 2020Actual

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 20, 2020

Last Update Posted Date

Jul 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Junqi Niu, Director of the department of Hepatology, The First Hospital of Jilin UniversityPrincipal Investigator

Lead Sponsor

The First Hospital of Jilin UniversityOTHER

Collaborators

Name	Class
Nanfang Hospital, Southern Medical University	OTHER
The Fourth Affiliated Hospital of Harbin Medical University	OTHER
Shandong Provincial Hospital	OTHER_GOV

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

This cross-sectional study will screen out hepatitis D virus-infected patients in HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among HBsAg positive people. The provinces of China are divided into 5 geographical areas (North, South, East, West and Central) to recruit patients according to the population density of each area. After statistical calculation, the total number of population needed is 3808.

Detailed Description

Entry criteria：1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV infection (HBsAg positive) 4.Ability to sign informed consent.

Exclusion criteria：Patients who disagree to participate in the trial.

After the informed consent was signed, the quantitative data of the previous surface antigen or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on the same day or the remaining serum from the surface antigen or hepatitis B quantitative test was collected for the detection of hepatitis D antibody and/or the quantitative detection of hepatitis D RNA.

After statistical analysis, calculate the hepatitis D infection status in China.

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

5,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HBV patients		HBV patients with HBsAg positive and/or HBV DNA positive

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of hepatitis D virus	Proportion of hepatitis D infection in people with hepatitis B infection	2019-2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hepatitis B surface antigen or HBV DNA positive

Exclusion Criteria:

Can't sign informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hepatitis B surface antigen or HBV DNA positive

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Junqi Niu, Dr.	The First Hospital of Jilin University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the first hospital of Jilin University		Changchun	Jilin	130021	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Infection rate data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided