A Hepatitis B With Hepatic Steatosis Study

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02392598

Acronym

HBHS

Enrollment

3000

Registered

2015-03-19

Start date

2015-08-31

Completion date

2020-12-31

Last updated

2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Steatosis, Hepatitis B, Chronic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
liver cirrhosis	5 years

Secondary

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

Countries

China

Contacts

Primary ContactJiangao Fan, MD

fattyliver2004@126.com

Backup ContactShiyan Yan, MD

shyyan2008phd@yahoo.com

Outcome results