A Hepatitis B With Hepatic Steatosis Study

Overview

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

Full Title of Study: “Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

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.

Clinical Trial Outcome Measures

Primary Measures

  • liver cirrhosis
    • Time Frame: 5 years

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fatty Liver and Alcoholic Liver Disease Study Group, China
  • Collaborator
    • Unimed Scientific Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jiangao Fan, MD, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Overall Contact(s)
    • Jiangao Fan, MD, fattyliver2004@126.com

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