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
  Purpose
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
Chronic Hepatitis B

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Enrollment: 818
Study Start Date: May 2012
Study Completion Date: November 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679769

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

Responsible Party: Guiqiang Wang, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01679769     History of Changes
Other Study ID Numbers: 2012-455  81170386 
Study First Received: September 1, 2012
Last Updated: November 4, 2015
Health Authority: China: Ethics Committee
China: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases

ClinicalTrials.gov processed this record on May 04, 2016