A Hepatitis B With Hepatic Steatosis Study
HBHS
Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B
1 other identifier
observational
3,000
1 country
7
Brief Summary
This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 5, 2015
August 1, 2015
5.3 years
March 13, 2015
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
liver cirrhosis
5 years
Secondary Outcomes (8)
liver cancer
5 years
liver failure
5 years
type 2 diabetes
5 years
cardiovascular and cerebrovascular events
5 years
death
5 years
- +3 more secondary outcomes
Eligibility Criteria
Any patients with chronic hepatisis B meeting eligibility criteria
You may qualify if:
- Clinically diagnosed chronic hepatitis B.
- Specific biopsy requirements for hepatic steatosis: qualified biopsy specimen within 6 months, \>5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
- Willing to participate in the long-term follow-up and cooperative.
- Able to provide informed consent file.
You may not qualify if:
- Unable to provide informed consent.
- Patients are eligible for baseline analysis but not eligible for follow-up, if having any of the following condition:
- Any end-stage liver disease.
- Any malignant tumor.
- Any congenital liver disease such as Wilson disease.
- Any other serious disease of projected survival \< 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Zhangzhou Zhengxing Hospital
Zhangzhou, Fujian, China
Shandong Provincial Hospital
Ji'nan, Shandong, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
Shanghai Xinhua Hospital
Shanghai, China
Biospecimen
Liver tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiangao Fan, MD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
March 19, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
August 5, 2015
Record last verified: 2015-08