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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01962155
First received: October 5, 2013
Last updated: March 28, 2016
Last verified: March 2016

October 5, 2013
March 28, 2016
August 2013
December 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
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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.
Up to Oct, 2015,total of 1800 patients with chronic HBV infection were enrolled. Paired blood and liver biopsy samples were collected. Blood samples stored at -80 degree Celsius. Liver biopsy samples were judged by three pathology experts.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
6 Months
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1841
December 2016
December 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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01962155
2013ZX10002005
Yes
Not Provided
Not Provided
Guiqiang Wang, Peking University First Hospital
Peking University First Hospital
Not Provided
Principal Investigator: Guiqiang Wang Peking University First Hospital
Peking University First Hospital
March 2016

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