Epidemiological Survey of Hepatitis D Virus Infection in China

NCT ID: NCT04483518

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-03

Study Completion Date

2020-07-07

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HBV patients

HBV patients with HBsAg positive and/or HBV DNA positive

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Hepatitis B surface antigen or HBV DNA positive

Exclusion Criteria

* Can't sign informed consent
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

The Fourth Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Junqi Niu

Director of the department of Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junqi Niu, Dr.

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Locations

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the first hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

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China

Other Identifiers

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19K056-001

Identifier Type: -

Identifier Source: org_study_id

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