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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 April 2014 by Peking University First Hospital
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital Identifier:
First received: October 5, 2013
Last updated: April 14, 2014
Last verified: April 2014

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
Estimated Primary Completion Date: August 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


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

  Hide Study Locations
China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China
Contact: Jiabin Li    13855148570   
Principal Investigator: Jiabin Li         
China, Beijing
Peking University First Hospital Recruiting
Bei Jing, Beijing, China, 100034
Contact: Guiqiang Wang, MD    86-13911405123   
Contact: Hong Zhao, MD    86-13810765942   
Principal Investigator: Guiqiang Wang, MD         
302 Military Hospital of China Recruiting
Beijing, Beijing, China, 100000
Contact: Liming Chen, MD    86-13021293636   
Principal Investigator: LiMing Chen, MD         
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 10000
Contact: Jun Cheng, MD    86-10-64281540   
Principal Investigator: Jun Cheng, MD         
China, Chongqing
The Second Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China
Contact: Dazhi Zhang, MD    86-13452382818   
Principal Investigator: Dazhi Zhang         
Southwest Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China
Contact: Xuqing Zhang    86-13527485619   
Principal Investigator: Xuqing Zhang         
China, Guangdong
Guangzhou Eighth People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Xiaobing Hu    13711307178   
Principal Investigator: Xiaobing Hu         
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Shibin Xie, MD    86-13922244948   
Principal Investigator: Shibin Xie         
The Third people's Hospital of Shenzhen Recruiting
Shenzhen, Guangdong, China
Contact: Yingxia Liu    13603096453   
Principal Investigator: Yingxia Liu         
China, Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China
Contact: Guo Zhang    13978839646   
Principal Investigator: Guo Zhang         
China, Hebei
The Third People's Hospital of Qinhuangdao Recruiting
Qinhuangdao, Hebei, China
Contact: Xun Peng    18603361960   
Principal Investigator: Xun Peng         
China, Henan
The Third Affiliated Hospital of Xinxiang Medical University Recruiting
Xinxiang, Henan, China
Contact: Weifeng Zhao    13837313280   
Principal Investigator: Weifeng Zhao         
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China
Contact: Jia Shang    13938401888   
Principal Investigator: Jia Shang         
China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China
Contact: Zuojiong Gong    13971687857   
Principal Investigator: Zuojiong Gong         
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Wangxian Tang    15907118789   
Principal Investigator: Wangxian Tang         
China, Hunan
The Second Xiangya Hospital of Central South Hospital Recruiting
Changsha, Hunan, China
Contact: Guozhong Gong    13873104819   
Principal Investigator: Guozhong Gong         
China, Jiangsu
81 Military Hospital of China Recruiting
Nanjing, Jiangsu, China
Contact: Maorong Wang    13401935666   
Principal Investigator: Maorong Wang         
The First Affiliated Hospital with Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Contact: Jun Li    13905175333   
Principal Investigator: Jun Li         
The Second Hospital of Nanjing Recruiting
Nanjing, Jiangsu, China
Contact: Wei Zhao    13951901772      
Principal Investigator: Wei Zhao         
China, Liaoning
Dalian the Sixth People's Hospital Recruiting
Dalian, Liaoning, China
Contact: Wanli Sun    13898657676      
Principal Investigator: Wanli Sun         
The Sixth People's Hospital of Shenyang Recruiting
Shenyang, Liaoning, China
Contact: Mingxiang Zhang    13386868855   
Principal Investigator: Mingxiang Zhang         
China, Shandong
Yantai City Hospital for Infectious Diseases Recruiting
Yantai, Shandong, China
Contact: Zhiqiang Zhou    13306387366   
Principal Investigator: Zhiqiang Zhou         
China, Shanxi
Shan Xi Medical University Recruiting
Taiyuan, Shanxi, China
Contact: Longfeng Zhao    13934519086      
Principal Investigator: Longfeng Zhao         
China, Zhejiang
Zhejiang First Hospital Recruiting
Hang Zhou, Zhejiang, China
Contact: Weifeng Liang, MD    86-13957163061   
Principal Investigator: Weifeng Liang         
Beijing Youan Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Jun Lv    13661381489   
Principal Investigator: Jun Lv         
China-Japan Friendship Hospital Recruiting
Beijing, China
Contact: Anlin Ma    13910253710   
Principal Investigator: Anlin Ma         
The 305 Hospital of People's Liberation Army Recruiting
Beijing, China
Contact: Zhijin Wang    15301018578      
Principal Investigator: Zhijin Wang         
West China Hospital, Sichuan University Recruiting
Chengdu, China
Contact: Liang Bai    86-18980602254   
Principal Investigator: Liang Bai         
Shanghai Public Health Clinical Center Recruiting
Shanghai, China
Contact: Zhanqing Zhang    18916039958   
Principal Investigator: Zhanqing Zhang         
Shanghai Ruijin Hospital Recruiting
Shanghai, China
Contact: Qing Xie    13651804273   
Principal Investigator: Qing Xie         
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: April 14, 2014
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
Hepatitis, Viral, Human
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 25, 2014