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

NCT ID: NCT01962155

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1841 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Hepatitis B Liver Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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chronic infected with hepatitis B virus

patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guiqiang Wang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guiqiang Wang

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

302 Military Hospital of China

Beijing, Beijing Municipality, China

Site Status

Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Southwest Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

Site Status

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

The Third people's Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status

The Third People's Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Site Status

The Third Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

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

Wuhan, Hubei, China

Site Status

The Second Xiangya Hospital of Central South Hospital

Changsha, Hunan, China

Site Status

81 Military Hospital of China

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Site Status

Dalian the Sixth People's Hospital

Dalian, Liaoning, China

Site Status

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

Site Status

Yantai City Hospital for Infectious Diseases

Yantai, Shandong, China

Site Status

Shan Xi Medical University

Taiyuan, Shanxi, China

Site Status

Zhejiang First Hospital

Hangzhou, Zhejiang, China

Site Status

Beijing Youan Hospital, Capital Medical University

Beijing, , China

Site Status

China-Japan Friendship Hospital

Beijing, , China

Site Status

The 305 Hospital of People's Liberation Army

Beijing, , China

Site Status

West China Hospital, Sichuan University

Chengdu, , China

Site Status

Shanghai Public Health Clinical Center

Shanghai, , China

Site Status

Shanghai Ruijin Hospital

Shanghai, , China

Site Status

Countries

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China

References

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Li J, Dong XQ, Cao LH, Zhang ZQ, Zhao WF, Shang QH, Zhang DZ, Ma AL, Xie Q, Gui HL, Zhang G, Liu YX, Shang J, Xie SB, Liu YQ, Zhang C, Wang GQ, Zhao H; China HepB Related Fibrosis Assessment Research Group. Factors associated with persistent positive in HBV DNA level in patients with chronic Hepatitis B receiving entecavir treatment. Front Cell Infect Microbiol. 2023 Jun 16;13:1151899. doi: 10.3389/fcimb.2023.1151899. eCollection 2023.

Reference Type DERIVED
PMID: 37396307 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33734135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31725459 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28962551 (View on PubMed)

Other Identifiers

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2013ZX10002005

Identifier Type: -

Identifier Source: org_study_id

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