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Completed

NCT Number: NCT01679769

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy

    Time frame: within two weeks after liver biopsy

Secondary outcomes

  1. Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy

    Time frame: within two weeks after liver biopsy

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Municipal Science & Technology Commission

Registry information

Official study title

Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 6, 2012
Registry last updated
Nov 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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