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CompletedNCT01962155HBVUpdated Sep 9, 2016

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

An observational study in Hepatitis B and Liver Fibrosis, sponsored by Peking University First Hospital. Completed at 30 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-09.

Sponsored by Peking University First Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,841
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis B
  • Liver Fibrosis

Keywords

  • Fibrosis
  • Liver Cirrhosis
  • non-invasive
  • biopsy
  • hepatitis B virus
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In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 1,841 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,841 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • chronic infected with hepatitis B virus

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

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What researchers measure

Primary outcomes

  1. 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

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Study locations

30 sites
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui, China
  • Peking University First Hospital
    Bei Jing, Beijing 100034, China
  • 302 Military Hospital of China
    Beijing, Beijing 100000, China
  • Beijing Ditan Hospital
    Beijing, Beijing 10000, China
  • Southwest Hospital, Third Military Medical University
    Chongqing, Chongqing, China
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing, China
  • 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
  • The People's Hospital of Guangxi Zhuang Autonomous Region
    Nanning, Guangxi, China
  • The Third People's Hospital of Qinhuangdao
    Qinhuangdao, Hebei, China
  • The Third Affiliated Hospital of Xinxiang Medical University
    Xinxiang, Henan, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan, China
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei, China
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
  • The Second Xiangya Hospital of Central South Hospital
    Changsha, Hunan, China
  • 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
  • Dalian the Sixth People's Hospital
    Dalian, Liaoning, China
  • The Sixth People's Hospital of Shenyang
    Shenyang, Liaoning, China
  • Yantai City Hospital for Infectious Diseases
    Yantai, Shandong, China
  • Shan Xi Medical University
    Taiyuan, Shanxi, China
  • Zhejiang First Hospital
    Hang Zhou, Zhejiang, 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
08

References and documents

Publications

  • 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. PubMed 33734135 ↗
  • 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. PubMed 31725459 ↗
  • 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. PubMed 28962551 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01962155
Lead sponsor
Peking University First Hospital
Responsible party
Guiqiang Wang (MD, Peking University First Hospital) — Principal investigator
First posted
Oct 14, 2013
Start date
Aug 2013
Primary completion
Dec 2015
Completion
Sep 2016
Last update
Sep 9, 2016

Study contacts

Guiqiang Wang
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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