A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.

February 24, 2022 updated by: Qin Ning
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Department and Institute of Infectious Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

age > 18 years chronic hepatitis B patients

Description

Inclusion Criteria: age > 18 years, chronic hepatitis B patients -

Exclusion Criteria: patients with chronic hepatitis C or D and human immunodeficiency virus co-infection, excessive alcohol intake (≥30 g/d for men, ≥20 g/d for women), other chronic liver diseases (e.g. primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease), or on medications known to induce hepatic steatosis (including corticosteroids, methotrexate, and tamoxifen), and pregnancy.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease progression
Time Frame: 3 years to 10 years
the effect of NAFLD on CHB
3 years to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qin Ning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 24, 2022

Primary Completion (Anticipated)

June 24, 2023

Study Completion (Anticipated)

June 24, 2030

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ20210524

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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