Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters
HBV
1 other identifier
observational
1,841
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2013
Typical duration for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 5, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 9, 2016
September 1, 2016
2.3 years
October 5, 2013
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
singular evaluation at the time of liver biopsy
Study Arms (1)
chronic infected with hepatitis B virus
patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy
Eligibility Criteria
patients infected with hepatitis B virus for at least 6 months
You may qualify if:
- HBsAg positive for at least 6 months
- agree to have liver biopsy
- Male or female aged 18 to 65 years old
You may not qualify if:
- Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
- platelet count \< 80000/L
- prothrombin activity ≤ 60%
- patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
302 Military Hospital of China
Beijing, Beijing Municipality, 100000, China
Beijing Ditan Hospital
Beijing, Beijing Municipality, 10000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Third people's Hospital of Shenzhen
Shenzhen, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Third People's Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South Hospital
Changsha, Hunan, China
81 Military Hospital of China
Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Dalian the Sixth People's Hospital
Dalian, Liaoning, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
Yantai City Hospital for Infectious Diseases
Yantai, Shandong, China
Shan Xi Medical University
Taiyuan, Shanxi, China
Zhejiang First Hospital
Hangzhou, Zhejiang, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
China-Japan Friendship Hospital
Beijing, China
The 305 Hospital of People's Liberation Army
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
Shanghai Public Health Clinical Center
Shanghai, China
Shanghai Ruijin Hospital
Shanghai, China
Related Publications (4)
Li J, Dong XQ, Cao LH, Zhang ZQ, Zhao WF, Shang QH, Zhang DZ, Ma AL, Xie Q, Gui HL, Zhang G, Liu YX, Shang J, Xie SB, Liu YQ, Zhang C, Wang GQ, Zhao H; China HepB Related Fibrosis Assessment Research Group. Factors associated with persistent positive in HBV DNA level in patients with chronic Hepatitis B receiving entecavir treatment. Front Cell Infect Microbiol. 2023 Jun 16;13:1151899. doi: 10.3389/fcimb.2023.1151899. eCollection 2023.
PMID: 37396307DERIVEDLi 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.
PMID: 33734135DERIVEDLi 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.
PMID: 31725459DERIVEDDeng 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.
PMID: 28962551DERIVED
Biospecimen
liver biopsy samples and blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guiqiang Wang
Peking University First Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 5, 2013
First Posted
October 14, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2015
Study Completion
September 1, 2016
Last Updated
September 9, 2016
Record last verified: 2016-09