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

Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01679769
Enrollment
818
Registered
2012-09-06
Start date
2012-05-31
Completion date
2015-11-30
Last updated
2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

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.

Interventions

None listed

Sponsors

Beijing Municipal Science & Technology Commission
CollaboratorOTHER
Peking University First Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsywithin two weeks after liver biopsy

Secondary

MeasureTime frame
Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsywithin two weeks after liver biopsy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026