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

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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