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NCT01679769 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

Official title:
Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01679769
Other study ID # 2012-455
Secondary ID 81170386
Status Completed
Phase N/A
First received September 1, 2012
Last updated November 4, 2015
Start date May 2012
Est. completion date November 2015

Study information
Verified date November 2015
Source Peking University First Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Ministry of Health
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 818
Est. completion date November 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking University First Hospital Bei Jing Beijing

Sponsors (2)
Lead Sponsor Collaborator
Peking University First Hospital Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy within two weeks after liver biopsy Yes
Secondary Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy within two weeks after liver biopsy Yes
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