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

Completed

• Conditions: Chronic Hepatitis B

• Registration Number: NCT01679769
• Lead Sponsor: Peking University First Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-09-01
• Study First Submitted QC: 2012-09-01
• Study First Posted: 2012-09-06
• Primary Completion: 2015-10
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 818

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy	within two weeks after liver biopsy

Secondary Outcome Measures

Name	Time	Method
Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy	within two weeks after liver biopsy

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Bei Jing, Beijing, China