NCT05255978

Brief Summary

This is a prospective/retrospective, observational follow-up study of effects of fatty liver on chronic hepatitis B. Patients will join this study who undergo transient elastography with liver stiffness (LS) and CAP measurements or Ultrasonic examination. All recruited subjects will undergo comprehensive clinical, anthropometric and laboratory assessments at the time when transient elastography or Ultrasonic examination is performed. We plan to compare the relationship between chronic hepatitis B and non-alcoholic fatty liver disease. Patients will be divided into several groups based on the demand.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Feb 2022Jun 2030

First Submitted

Initial submission to the registry

February 16, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2023

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2030

Expected
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

February 16, 2022

Last Update Submit

February 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • disease progression

    the effect of NAFLD on CHB

    3 years to 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

age \> 18 years chronic hepatitis B patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department and Institute of Infectious Disease

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

blood

Central Study Contacts

Ning Qin, Doctor

CONTACT

Meifang Han, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director and Chair of Department of Infectious Diseases

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

February 24, 2022

Primary Completion

June 24, 2023

Study Completion (Estimated)

June 24, 2030

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations