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

November 4, 2015 updated by: Guiqiang Wang, Peking University First Hospital

Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

818

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Bei Jing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus (HBV) infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy
Time Frame: within two weeks after liver biopsy
within two weeks after liver biopsy

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy
Time Frame: within two weeks after liver biopsy
within two weeks after liver biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Beijing Municipal Science & Technology Commission

Investigators

  • Principal Investigator: Guiqiang Wang, MD, Peking University First Hospital
  • Study Director: Hong Zhao, MD, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 1, 2012

First Submitted That Met QC Criteria

September 1, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-455
  • 81170386 (Other Grant/Funding Number: from The National Natural Science Foundation of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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