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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Peking University First Hospital
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: April 14, 2014
Last verified: April 2014
  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:
  • Quality of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: singular evaluation at the time of liver biopsy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of staging inflammation with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: singular evaluation at the time of liver biopsy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

liver biopsy samples and blood samples


Estimated Enrollment: 720
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
  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

Contacts
Contact: hong zhao, MD 13810765943 minmin2001@gmail.com
Contact: Guiqiang Wang, MD 13911405123 john131212@126.com

Locations
China, Beijing
Peking University First Hospital Recruiting
Bei Jing, Beijing, China, 100034
Contact: Ying Wang    86-10-66551211      
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

No publications provided

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: April 14, 2014
Health Authority: China: Ethics Committee
China: Ministry of Health

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 18, 2014