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

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ClinicalTrials.gov Identifier: NCT01679769
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : November 6, 2015
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital

Study Description
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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.

Condition or disease
Chronic Hepatitis B

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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 818 participants
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic
Study Start Date : May 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: within two weeks after liver biopsy ]

Biospecimen Retention:   Samples Without DNA
liver biopsy samples and blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus (HBV) infection
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679769


Locations
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China, Beijing
Peking University First Hospital
Bei Jing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Beijing Municipal Science & Technology Commission
Investigators
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Principal Investigator: Guiqiang Wang, MD Peking University First Hospital
Study Director: Hong Zhao, MD Peking University First Hospital
More Information
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Additional Information:

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Responsible Party: Guiqiang Wang, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01679769    
Other Study ID Numbers: 2012-455
81170386 ( Other Grant/Funding Number: from The National Natural Science Foundation of China )
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections