HBHS: A Hepatitis B With Hepatic Steatosis Study

• Sponsor: Fatty Liver and Alcoholic Liver Disease Study Group, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02392598
• Collaborator: Unimed Scientific Inc. (Industry)
• Enrollment: 3,000
• Locations: 7
• Duration (Months): 64
• Patients Per Site: 428.6
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic; Hepatic Steatosis

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 Design

• Study Type: Observational
• Anticipated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B
• Study Start Date: Aug 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Outcome Measures

Primary Outcome Measures

1. liver cirrhosis [5 years]

Secondary Outcome Measures

1. liver cancer [5 years]

2. liver failure [5 years]

3. type 2 diabetes [5 years]

4. cardiovascular and cerebrovascular events [5 years]

5. death [5 years]

6. response of hepatic steatosis to anti-virus treatment [1 year]

7. effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment [1 year]

8. effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

3. Any end-stage liver disease.

4. Any malignant tumor.

5. Any congenital liver disease such as Wilson disease.

6. Any other serious disease of projected survival < 5 years.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhangzhou Zhengxing Hospital	Zhangzhou	Fujian	China
2	Shandong Provincial Hospital	Ji'nan	Shandong	China
3	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan	China
4	Tianjin Second People's Hospital	Tianjin	Tianjin	China
5	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China
6	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang	China
7	Shanghai Xinhua Hospital	Shanghai		China

Sponsors and Collaborators

• Fatty Liver and Alcoholic Liver Disease Study Group, China
• Unimed Scientific Inc.

Investigators

• Principal Investigator: Jiangao Fan, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatty Liver and Alcoholic Liver Disease Study Group, China
• ClinicalTrials.gov Identifier: NCT02392598
• Other Study ID Numbers: HBV2015
• First Posted: Mar 19, 2015
• Last Update Posted: Aug 5, 2015
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Fatty Liver

Study Results

No Results Posted as of Aug 5, 2015