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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Liver Fibrosis

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.

• Study Type: Observational
• Enrollment (Actual): 1841

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Youan Hospital, Capital Medical University
  • Beijing, China
    • China-Japan Friendship Hospital
  • Beijing, China
    • The 305 Hospital of People's Liberation Army
  • Chengdu, China
    • West China Hospital, Sichuan University
  • Shanghai, China
    • Shanghai Public Health Clinical Center
  • Shanghai, China
    • Shanghai Ruijin Hospital
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing
    • Bei Jing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100000
      • 302 Military Hospital of China
    • Beijing, Beijing, China, 10000
      • Beijing Ditan Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Southwest Hospital, Third Military Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangzhou Eighth People's Hospital
    • Guangzhou, Guangdong, China
      • The third affiliated hospital of Sun Yat-Sen University
    • Shenzhen, Guangdong, China
      • The Third People's Hospital of Shenzhen
  • Guangxi
    • Nanning, Guangxi, China
      • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Hebei
    • Qinhuangdao, Hebei, China
      • The Third People's Hospital of Qinhuangdao
  • Henan
    • Xinxiang, Henan, China
      • The Third Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • 81 Military Hospital of China
    • Nanjing, Jiangsu, China
      • The Second Hospital of Nanjing
    • Nanjing, Jiangsu, China
      • The First Affiliated Hospital with Nanjing Medical University
  • Liaoning
    • Dalian, Liaoning, China
      • Dalian the Sixth People's Hospital
    • Shenyang, Liaoning, China
      • The Sixth People's Hospital of Shenyang
  • Shandong
    • Yantai, Shandong, China
      • Yantai City Hospital for Infectious Diseases
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shan Xi Medical University
  • Zhejiang
    • Hang Zhou, Zhejiang, China
      • Zhejiang First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients infected with hepatitis B virus for at least 6 months

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
chronic infected with hepatitis B virus; patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 5, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Fibrosis; Liver Cirrhosis; non-invasive; biopsy; hepatitis B virus
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Fibrosis; Hepatitis B; Hepatitis; Hepatitis A; Liver Cirrhosis
• Other Study ID Numbers: 2013ZX10002005