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
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Condition or disease |
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Chronic Hepatitis B |
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 |

- Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: within two weeks after liver biopsy ]
- 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

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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 |
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

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
China, Beijing | |
Peking University First Hospital | |
Bei Jing, Beijing, China, 100034 |
Principal Investigator: | Guiqiang Wang, MD | Peking University First Hospital | |
Study Director: | Hong Zhao, MD | Peking University First Hospital |
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 |
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 |