NCT04483518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 20, 2020

Last Update Submit

July 20, 2020

Conditions

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

Keywords

HBsAg positiveHBV DNA

Outcome Measures

Primary Outcomes (1)

  • The prevalence of hepatitis D virus

    Proportion of hepatitis D infection in people with hepatitis B infection

    2019-2020

Study Arms (1)

HBV patients

HBV patients with HBsAg positive and/or HBV DNA positive

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hepatitis B surface antigen or HBV DNA positive

You may qualify if:

  • Hepatitis B surface antigen or HBV DNA positive

You may not qualify if:

  • Can't sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples are used to detect HDV antibodies or HDV RNA

Study Officials

  • Junqi Niu, Dr.

    The First Hospital of Jilin University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of Hepatology

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 23, 2020

Study Start

June 3, 2019

Primary Completion

July 7, 2020

Study Completion

July 7, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Infection rate data

Locations

CN(1)