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 November 2015 by Peking University First Hospital
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital Identifier:
First received: October 5, 2013
Last updated: November 4, 2015
Last verified: November 2015
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.

Hepatitis B
Liver Fibrosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus

Resource links provided by NLM:

Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 2000
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
chronic infected with hepatitis B virus
patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients infected with hepatitis B virus for at least 6 months

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
  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 identifier: NCT01962155

Contact: Guiqiang Wang 13911405123
Contact: Hong Zhao 13810765943

  Show 30 Study Locations
Sponsors and Collaborators
Peking University First Hospital
Principal Investigator: Guiqiang Wang Peking University First Hospital
  More Information

No publications provided

Responsible Party: Guiqiang Wang, MD, Peking University First Hospital Identifier: NCT01962155     History of Changes
Other Study ID Numbers: 2013ZX10002005
Study First Received: October 5, 2013
Last Updated: November 4, 2015
Health Authority: China: Ministry of Health

Keywords provided by Peking University First Hospital:
Liver Cirrhosis
hepatitis B virus

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 27, 2015