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

This study has been completed.
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01679769
First received: September 1, 2012
Last updated: November 4, 2015
Last verified: November 2015

September 1, 2012
November 4, 2015
May 2012
October 2015   (final data collection date for primary outcome measure)
Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: within two weeks after liver biopsy ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01679769 on ClinicalTrials.gov Archive Site
Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: within two weeks after liver biopsy ] [ Designated as safety issue: Yes ]
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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
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.
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.
Observational [Patient Registry]
Time Perspective: Prospective
2 Weeks
Retention:   Samples Without DNA
Description:
liver biopsy samples and blood samples
Non-Probability Sample
patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus (HBV) infection
Chronic Hepatitis B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
818
November 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01679769
2012-455, 81170386
Yes
Not Provided
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Guiqiang Wang, Peking University First Hospital
Peking University First Hospital
Beijing Municipal Science & Technology Commission
Principal Investigator: Guiqiang Wang, MD Peking University First Hospital
Study Director: Hong Zhao, MD Peking University First Hospital
Peking University First Hospital
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP