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Completed

NCT Number: NCT01962155

Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters

The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

Up to Oct, 2015,total of 1800 patients with chronic HBV infection were enrolled. Paired blood and liver biopsy samples were collected. Blood samples stored at -80 degree Celsius. Liver biopsy samples were judged by three pathology experts.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HBsAg positive for at least 6 months
  • agree to have liver biopsy
  • Male or female aged 18 to 65 years old

Exclusion criteria

  • Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
  • platelet count < 80000/L
  • prothrombin activity ≤ 60%
  • patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Treatment and study plan

Primary outcomes

  1. determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis B

    Time frame: singular evaluation at the time of liver biopsy

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus

Acronym: HBV

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 14, 2013
Registry last updated
Sep 9, 2016

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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