Clinical trial NCT01962155: Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters
Official title: Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Liver Fibrosis
Keywords: Fibrosis
Liver Cirrhosis
non-invasive
biopsy
hepatitis B virus
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 1841
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients infected with hepatitis B virus for at least 6 months

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: singular evaluation at the time of liver biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Bei Jing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: 302 Military Hospital of China
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital, Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: The Third people's Hospital of Shenzhen
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Qinhuangdao
country: China
facility: The Third People's Hospital of Qinhuangdao
state: Hebei
city: Xinxiang
country: China
facility: The Third Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South Hospital
state: Hunan
city: Nanjing
country: China
facility: 81 Military Hospital of China
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Dalian
country: China
facility: Dalian the Sixth People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
state: Liaoning
city: Yantai
country: China
facility: Yantai City Hospital for Infectious Diseases
state: Shandong
city: Taiyuan
country: China
facility: Shan Xi Medical University
state: Shanxi
city: Hang Zhou
country: China
facility: Zhejiang First Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: The 305 Hospital of People's Liberation Army
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Wu Z, Wang GQ, Zhao H. Hepatitis B core-related antigen reflects viral replication and protein production in chronic hepatitis B patients. Chin Med J (Engl). 2021 Mar 17;134(10):1160-1167. doi: 10.1097/CM9.0000000000001418.
citation: Li J, Dong XQ, Wu Z, Ma AL, Xie SB, Zhang XQ, Zhang ZQ, Zhang DZ, Zhao WF, Zhang G, Cheng J, Xie Q, Li J, Zou ZQ, Liu YX, Wang GQ, Zhao H; China Hepatitis B Related Fibrosis Assessment Research Group. Unsatisfying antiviral therapeutic effect in patients with mother-to-child transmissed chronic hepatitis B virus infection: a prospective multi-center clinical study. Chin Med J (Engl). 2019 Nov 20;132(22):2647-2656. doi: 10.1097/CM9.0000000000000522.
citation: Deng Y, Zhao H, Zhou J, Yan L, Wang G; China HepB-Related Fibrosis Assessment Research Group. Angiopoietin-like protein as a novel marker for liver fibrosis in chronic hepatitis B patients with normal to minimally raised ALT. BMC Infect Dis. 2017 Sep 29;17(1):650. doi: 10.1186/s12879-017-2728-7.