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
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01962155
First received: October 5, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition
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)
Groups/Cohorts
chronic infected with hepatitis B virus
patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy

  Eligibility

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

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
  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 ClinicalTrials.gov identifier: NCT01962155

Contacts
Contact: Guiqiang Wang 13911405123 john131212@126.com
Contact: Hong Zhao 13810765943 minmin2001@gmail.com

  Hide Study Locations
Locations
China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China
Contact: Jiabin Li    13855148570    lijiabin948@163.com   
Principal Investigator: Jiabin Li         
China, Beijing
Peking University First Hospital Recruiting
Bei Jing, Beijing, China, 100034
Contact: Guiqiang Wang, MD    86-13911405123    john131212@hotmail.com   
Contact: Hong Zhao, MD    86-13810765942    minmin2001@gmail.com   
Principal Investigator: Guiqiang Wang, MD         
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 10000
Contact: Jun Cheng, MD    86-10-64281540    jun.cheng@bjditan.org   
Principal Investigator: Jun Cheng, MD         
302 Military Hospital of China Recruiting
Beijing, Beijing, China, 100000
Contact: Liming Chen, MD    86-13021293636    hm160@sina.cn   
Principal Investigator: LiMing Chen, MD         
China, Chongqing
Southwest Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China
Contact: Xuqing Zhang    86-13527485619    xuqing651005@tom.com   
Principal Investigator: Xuqing Zhang         
The Second Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China
Contact: Dazhi Zhang, MD    86-13452382818    zhangdzh@etang.com   
Principal Investigator: Dazhi Zhang         
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Shibin Xie, MD    86-13922244948    xieshibin1964@163.com   
Principal Investigator: Shibin Xie         
Guangzhou Eighth People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Xiaobing Hu    13711307178    Dr.HXB@163.com   
Principal Investigator: Xiaobing Hu         
The Third people's Hospital of Shenzhen Recruiting
Shenzhen, Guangdong, China
Contact: Yingxia Liu    13603096453    yingxialiu@hotmail.com   
Principal Investigator: Yingxia Liu         
China, Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China
Contact: Guo Zhang    13978839646    zhangguogx@hotmail.com   
Principal Investigator: Guo Zhang         
China, Hebei
The Third People's Hospital of Qinhuangdao Recruiting
Qinhuangdao, Hebei, China
Contact: Xun Peng    18603361960    pengxun1960@163.com   
Principal Investigator: Xun Peng         
China, Henan
The Third Affiliated Hospital of Xinxiang Medical University Recruiting
Xinxiang, Henan, China
Contact: Weifeng Zhao    13837313280    zwf7577@126.com   
Principal Investigator: Weifeng Zhao         
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China
Contact: Jia Shang    13938401888    shangjia666@126.com   
Principal Investigator: Jia Shang         
China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China
Contact: Zuojiong Gong    13971687857    zjgong@163.com   
Principal Investigator: Zuojiong Gong         
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Wangxian Tang    15907118789    tangwx@tjh.tjmu.edu.cn   
Principal Investigator: Wangxian Tang         
China, Hunan
The Second Xiangya Hospital of Central South Hospital Recruiting
Changsha, Hunan, China
Contact: Guozhong Gong    13873104819    guozhonggong@yahoo.com   
Principal Investigator: Guozhong Gong         
China, Jiangsu
The Second Hospital of Nanjing Recruiting
Nanjing, Jiangsu, China
Contact: Wei Zhao    13951901772      
Principal Investigator: Wei Zhao         
81 Military Hospital of China Recruiting
Nanjing, Jiangsu, China
Contact: Maorong Wang    13401935666    maorongwang@126.com   
Principal Investigator: Maorong Wang         
The First Affiliated Hospital with Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Contact: Jun Li    13905175333    prof.lijun@gmail.com   
Principal Investigator: Jun Li         
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    zmx6511@126.com   
Principal Investigator: Mingxiang Zhang         
China, Shandong
Yantai City Hospital for Infectious Diseases Recruiting
Yantai, Shandong, China
Contact: Zhiqiang Zhou    13306387366    zhiqiangzou@126.com   
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    dr.liangwf@163.com   
Principal Investigator: Weifeng Liang         
China
The 305 Hospital of People's Liberation Army Recruiting
Beijing, China
Contact: Zhijin Wang    15301018578      
Principal Investigator: Zhijin Wang         
Beijing Youan Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Jun Lv    13661381489    lujun98@ccmu.edu.com   
Principal Investigator: Jun Lv         
China-Japan Friendship Hospital Recruiting
Beijing, China
Contact: Anlin Ma    13910253710    maanlinjc@163.com   
Principal Investigator: Anlin Ma         
West China Hospital, Sichuan University Recruiting
Chengdu, China
Contact: Liang Bai    86-18980602254    pangbailang@163.com   
Principal Investigator: Liang Bai         
Shanghai Public Health Clinical Center Recruiting
Shanghai, China
Contact: Zhanqing Zhang    18916039958    doctorzzqsphc@163.com   
Principal Investigator: Zhanqing Zhang         
Shanghai Ruijin Hospital Recruiting
Shanghai, China
Contact: Qing Xie    13651804273    xieqingrjh@163.com   
Principal Investigator: Qing Xie         
Sponsors and Collaborators
Peking University First Hospital
Investigators
Principal Investigator: Guiqiang Wang Peking University First Hospital
  More Information

No publications provided

Responsible Party: Guiqiang Wang, MD, Peking University First Hospital
ClinicalTrials.gov 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:
Fibrosis
Liver Cirrhosis
non-invasive
biopsy
hepatitis B virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Fibrosis
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014