A Hepatitis B With Hepatic Steatosis Study

• Conditions: Hepatic Steatosis; Hepatitis B, Chronic

• Registration Number: NCT02392598
• Lead Sponsor: Fatty Liver and Alcoholic Liver Disease Study Group, China

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.

Study Timeline

• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Status Verified: 2015-08
• Study Start: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
liver cirrhosis	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (7)

The Affiliated Hospital of Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China

Tianjin Second People's Hospital; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China

Zhangzhou Zhengxing Hospital; 🇨🇳 Zhangzhou, Fujian, China

Shandong Provincial Hospital; 🇨🇳 Ji'nan, Shandong, China

Shanghai Xinhua Hospital; 🇨🇳 Shanghai, China