A Hepatitis B With Hepatic Steatosis Study (HBHS)

August 3, 2015 updated by: Fatty Liver and Alcoholic Liver Disease Study Group, China

Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B

This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with chronic hepatisis B will be enrolled in the study and followed up after 1 year, 3 years and 5 years with a visit window of +1 month.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China
        • Shanghai Xinhua hospital
    • Fujian
      • Zhangzhou, Fujian, China
        • Zhangzhou Zhengxing Hospital
    • Shandong
      • Ji'nan, Shandong, China
        • Shandong Provincial Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Second People's Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Affiliated Hospital of Hangzhou Normal University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patients with chronic hepatisis B meeting eligibility criteria

Description

Inclusion Criteria:

  1. Clinically diagnosed chronic hepatitis B.
  2. Specific biopsy requirements for hepatic steatosis: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
  3. Willing to participate in the long-term follow-up and cooperative.
  4. Able to provide informed consent file.

Exclusion Criteria:

  1. Unable to provide informed consent.

  2. Patients are eligible for baseline analysis but not eligible for follow-up, if having any of the following condition:

    1. Any end-stage liver disease.
    2. Any malignant tumor.
    3. Any congenital liver disease such as Wilson disease.
    4. Any other serious disease of projected survival < 5 years.

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
Time Frame
liver cirrhosis
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
liver cancer
Time Frame: 5 years
5 years
liver failure
Time Frame: 5 years
5 years
type 2 diabetes
Time Frame: 5 years
5 years
cardiovascular and cerebrovascular events
Time Frame: 5 years
5 years
death
Time Frame: 5 years
5 years
response of hepatic steatosis to anti-virus treatment
Time Frame: 1 year
1 year
effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment
Time Frame: 1 year
1 year
effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Fatty Liver and Alcoholic Liver Disease Study Group, China

Collaborators

Unimed Scientific Inc.

Investigators

  • Principal Investigator: Jiangao Fan, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

August 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV2015

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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