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ClinicalTrials.gov ID

NCT02392598

Lead Sponsor

Fatty Liver and Alcoholic Liver Disease Study Group, ChinaOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

3,000Estimated

Last Update Posted

Aug 5, 2015Estimated

Start Date

Aug 2015

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

Official Title

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

Brief Summary

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

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.

• Hepatitis B, Chronic
• Hepatic Steatosis

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fatty Liver and Alcoholic Liver Disease Study Group, ChinaOTHER

Collaborators

Unimed Scientific Inc.INDUSTRY

fattyliver2004@126.com