Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B

NCT ID: NCT01679769

Last Updated: 2015-11-06

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

COMPLETED

Total Enrollment

818 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-11-30

Brief Summary

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The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with chronic hepatitis B in mainland China.

Detailed Description

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Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts, according to Ishak standard.

Conditions

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Chronic Hepatitis B

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of chronic hepatitis B or compensated cirrhosis due to chronic hepatitis B virus infection
* agree to have liver biopsy

Exclusion Criteria

* clinical diagnosis of decompensated cirrhosis due to hepatitis B virus or inactive carrier
* liver diseases due to other origin
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guiqiang Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guiqiang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Hong Zhao, MD

Role: STUDY_DIRECTOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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81170386

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012-455

Identifier Type: -

Identifier Source: org_study_id

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