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

Completed
Conditions
Hepatitis B
Liver Fibrosis
Registration Number
NCT01962155
Lead Sponsor
Peking University First Hospital
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1841
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Bsingular evaluation at the time of liver biopsy
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (30)

The Second Affiliated Hospital of Chongqing Medical University

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Chongqing, Chongqing, China

The People's Hospital of Guangxi Zhuang Autonomous Region

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Nanning, Guangxi, China

Henan Provincial People's Hospital

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Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South Hospital

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Changsha, Hunan, China

Renmin Hospital of Wuhan University

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Wuhan, Hubei, China

The Third Affiliated Hospital of Xinxiang Medical University

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Xinxiang, Henan, China

The Third Affiliated Hospital of Sun Yat-sen University

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Guangzhou, Guangdong, China

The First Affiliated Hospital of Anhui Medical University

πŸ‡¨πŸ‡³

Hefei, Anhui, China

Southwest Hospital, Third Military Medical University

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Chongqing, Chongqing, China

Shanghai Public Health Clinical Center

πŸ‡¨πŸ‡³

Shanghai, China

Shanghai Ruijin Hospital

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Shanghai, China

Guangzhou Eighth People's Hospital

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Guangzhou, Guangdong, China

The First Affiliated Hospital with Nanjing Medical University

πŸ‡¨πŸ‡³

Nanjing, Jiangsu, China

China-Japan Friendship Hospital

πŸ‡¨πŸ‡³

Beijing, China

The Third people's Hospital of Shenzhen

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Shenzhen, Guangdong, China

The Third People's Hospital of Qinhuangdao

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Qinhuangdao, Hebei, China

Yantai City Hospital for Infectious Diseases

πŸ‡¨πŸ‡³

Yantai, Shandong, China

Shan Xi Medical University

πŸ‡¨πŸ‡³

Taiyuan, Shanxi, China

302 Military Hospital of China

πŸ‡¨πŸ‡³

Beijing, Beijing, China

The Second Hospital of Nanjing

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Nanjing, Jiangsu, China

Beijing Ditan Hospital

πŸ‡¨πŸ‡³

Beijing, Beijing, China

Zhejiang First Hospital

πŸ‡¨πŸ‡³

Hang Zhou, Zhejiang, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

πŸ‡¨πŸ‡³

Wuhan, Hubei, China

81 Military Hospital of China

πŸ‡¨πŸ‡³

Nanjing, Jiangsu, China

Dalian the Sixth People's Hospital

πŸ‡¨πŸ‡³

Dalian, Liaoning, China

West China Hospital, Sichuan University

πŸ‡¨πŸ‡³

Chengdu, China

The Sixth People's Hospital of Shenyang

πŸ‡¨πŸ‡³

Shenyang, Liaoning, China

Beijing Youan Hospital, Capital Medical University

πŸ‡¨πŸ‡³

Beijing, China

The 305 Hospital of People's Liberation Army

πŸ‡¨πŸ‡³

Beijing, China

Peking University First Hospital

πŸ‡¨πŸ‡³

Bei Jing, Beijing, China

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