A Hepatitis B With Hepatic Steatosis Study

Hepatitis B, Chronic Clinical Trial

— HBHS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02392598
• Other study ID #: HBV2015
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2015
• Last updated: August 3, 2015
• Start date: August 2015
• Est. completion date: December 2020

Study information

• Verified date: August 2015
• Source: Fatty Liver and Alcoholic Liver Disease Study Group, China
• Contact: Jiangao Fan, MD
• Email: fattyliver2004[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
China	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Ji'nan	Shandong
China	Shanghai Xinhua Hospital	Shanghai
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

Sponsors (2)

Lead Sponsor	Collaborator
Fatty Liver and Alcoholic Liver Disease Study Group, China	Unimed Scientific Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver cirrhosis		5 years	No
Secondary	liver cancer		5 years	No
Secondary	liver failure		5 years	No
Secondary	type 2 diabetes		5 years	No
Secondary	cardiovascular and cerebrovascular events		5 years	No
Secondary	death		5 years	No
Secondary	response of hepatic steatosis to anti-virus treatment		1 year	No
Secondary	effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment		1 year	No
Secondary	effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment		1 year	No