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

Peking University

Status: Completed

Conditions: Liver Fibrosis; Hepatitis B

Study type: Observational

Funder types: Other

Identifiers

NCT01962155

2013ZX10002005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,841 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,841 participants in 1 patient group

chronic infected with hepatitis B virus

Description:

patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy