Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 1, 2012
First Posted Date September 6, 2012
Last Update Posted Date November 6, 2015
Study Start Date May 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2015)
Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: within two weeks after liver biopsy ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: November 28, 2014)
Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy [ Time Frame: within two weeks after liver biopsy ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B
Official Title Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic
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.
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 Type Observational [Patient Registry]
Study Design Time Perspective: Prospective
Target Follow-Up Duration 2 Weeks
Biospecimen Retention:   Samples Without DNA
Description:
liver biopsy samples and blood samples
Sampling Method Non-Probability Sample
Study Population patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus (HBV) infection
Condition Chronic Hepatitis B
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 4, 2015)
818
Original Estimated Enrollment
 (submitted: September 1, 2012)
720
Actual Study Completion Date November 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01679769
Other Study ID Numbers 2012-455
81170386 ( Other Grant/Funding Number: from The National Natural Science Foundation of China )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Guiqiang Wang, Peking University First Hospital
Study Sponsor Peking University First Hospital
Collaborators Beijing Municipal Science & Technology Commission
Investigators
Principal Investigator: Guiqiang Wang, MD Peking University First Hospital
Study Director: Hong Zhao, MD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date November 2015