A Hepatitis B With Hepatic Steatosis Study

NCT ID: NCT02392598

Last Updated: 2015-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatitis B, Chronic Hepatic Steatosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unimed Scientific Inc.

INDUSTRY

Sponsor Role collaborator

Fatty Liver and Alcoholic Liver Disease Study Group, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiangao Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Zhangzhou Zhengxing Hospital

Zhangzhou, Fujian, China

Site Status

Shandong Provincial Hospital

Ji'nan, Shandong, China

Site Status

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status

Shanghai Xinhua Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Jiangao Fan, MD

Role: CONTACT

Shiyan Yan, MD

Role: CONTACT

Facility Contacts

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Ruidan Zheng, MD

Role: primary

Wanhua Ren, MD

Role: primary

Liangping Li, MD

Role: primary

Yuqiang Mi, MD

Role: primary

Fangping He, MD

Role: primary

Junping Shi, MD

Role: primary

Jiangao Fan, MD

Role: primary

Other Identifiers

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HBV2015

Identifier Type: -

Identifier Source: org_study_id

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