Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters (HBV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Peking University First Hospital
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01962155
First received: October 5, 2013
Last updated: April 14, 2014
Last verified: April 2014

October 5, 2013
April 14, 2014
August 2013
August 2015   (final data collection date for primary outcome measure)
determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis B [ Time Frame: singular evaluation at the time of liver biopsy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01962155 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters
Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus

The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Weeks
Retention:   Samples Without DNA
Description:

liver biopsy samples and blood samples

Probability Sample

patients infected with hepatitis B virus for at least 6 months

  • Hepatitis B
  • Liver Fibrosis
Not Provided
chronic infected with hepatitis B virus
patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. HBsAg positive for at least 6 months
  2. agree to have liver biopsy
  3. Male or female aged 18 to 65 years old

Exclusion Criteria:

  1. Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
  2. platelet count < 80000/L
  3. prothrombin activity ≤ 60%
  4. patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Both
18 Years to 65 Years
No
Contact: Guiqiang Wang 13911405123 john131212@126.com
Contact: Hong Zhao 13810765943 minmin2001@gmail.com
China
 
NCT01962155
2013ZX10002005
Yes
Guiqiang Wang, Peking University First Hospital
Peking University First Hospital
Not Provided
Principal Investigator: Guiqiang Wang Peking University First Hospital
Peking University First Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP