Clinical trial NCT02392598: A Hepatitis B With Hepatic Steatosis Study
Official title: Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Hepatic Steatosis
Lead sponsor: Fatty Liver and Alcoholic Liver Disease Study Group, China
Sponsor class: OTHER
Collaborators: name: Unimed Scientific Inc.
First posted: 2015-03-19
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients with chronic hepatisis B meeting eligibility criteria

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.

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.

Primary outcomes:
measure: liver cirrhosis
timeFrame: 5 years
Secondary outcomes:
measure: liver cancer
timeFrame: 5 years
measure: liver failure
timeFrame: 5 years
measure: type 2 diabetes
timeFrame: 5 years
measure: cardiovascular and cerebrovascular events
timeFrame: 5 years
measure: death
timeFrame: 5 years
measure: response of hepatic steatosis to anti-virus treatment
timeFrame: 1 year
measure: effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment
timeFrame: 1 year
measure: effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Zhengxing Hospital
state: Fujian
city: Ji'nan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jiangao Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: