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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01962155
First received: October 5, 2013
Last updated: September 8, 2016
Last verified: September 2016
  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: 6 Months
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

Enrollment: 1841
Study Start Date: August 2013
Study Completion Date: September 2016
Primary Completion Date: December 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

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

  Hide Study Locations
Locations
China, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
China, Beijing
Peking University First Hospital
Bei Jing, Beijing, China, 100034
302 Military Hospital of China
Beijing, Beijing, China, 100000
Beijing Ditan Hospital
Beijing, Beijing, China, 10000
China, Chongqing
Southwest Hospital, Third Military Medical University
Chongqing, Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China
China, Guangdong
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
China, Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
China, Hebei
The Third People's Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
China, Henan
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
China, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Hunan
The Second Xiangya Hospital of Central South Hospital
Changsha, Hunan, China
China, Jiangsu
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
China, Liaoning
Dalian the Sixth People's Hospital
Dalian, Liaoning, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
China, Shandong
Yantai City Hospital for Infectious Diseases
Yantai, Shandong, China
China, Shanxi
Shan Xi Medical University
Taiyuan, Shanxi, China
China, Zhejiang
Zhejiang First Hospital
Hang Zhou, Zhejiang, China
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
Sponsors and Collaborators
Peking University First Hospital
Investigators
Principal Investigator: Guiqiang Wang Peking University First Hospital
  More Information

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: September 8, 2016
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
Fibrosis
Hepatitis B
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on December 07, 2016