Hepatitis BHBVNCT01962155
Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters
An observational study of Hepatitis B and Liver Fibrosis, run by Peking University First Hospital at 30 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Liver Fibrosis
- How many people
- 1,841 participants
- Where
- 30 sitesChina
- Study dates
- Aug 2013to Sep 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients infected with hepatitis B virus for at least 6 months
Who may be able to join
- HBsAg positive for at least 6 months
- agree to have liver biopsy
- Male or female aged 18 to 65 years old
Who cannot join
- Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
- platelet count < 80000/L
- prothrombin activity ≤ 60%
- patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
302 Military Hospital of China
Beijing, Beijing Municipality, 100000
Beijing Ditan Hospital
Beijing, Beijing Municipality, 10000
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Youan Hospital, Capital Medical University
Beijing
China-Japan Friendship Hospital
Beijing
The 305 Hospital of People's Liberation Army
Beijing
The Second Xiangya Hospital of Central South Hospital
Changsha, Hunan
West China Hospital, Sichuan University
Chengdu
Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Dalian the Sixth People's Hospital
Dalian, Liaoning
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Zhejiang First Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
81 Military Hospital of China
Nanjing, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
The Second Hospital of Nanjing
Nanjing, Jiangsu
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
The Third People's Hospital of Qinhuangdao
Qinhuangdao, Hebei
Shanghai Public Health Clinical Center
Shanghai
Shanghai Ruijin Hospital
Shanghai
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning
The Third people's Hospital of Shenzhen
Shenzhen, Guangdong
Shan Xi Medical University
Taiyuan, Shanxi
Renmin Hospital of Wuhan University
Wuhan, Hubei
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
Yantai City Hospital for Infectious Diseases
Yantai, Shandong
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
Official title: Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus
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.
- Conditions
- Hepatitis B, Liver Fibrosis
- Keywords
- Fibrosis, Liver Cirrhosis, non-invasive, biopsy, hepatitis B virus
- Medical subject headings
- Hepatitis B, Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic infected with hepatitis B virus | patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: singular evaluation at the time of liver biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,841 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guiqiang Wang, Peking University First Hospital
- Investigators
- Guiqiang Wang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962155
- Sponsor's protocol ID
- 2013ZX10002005
- Acronym
- HBV
- Status last verified
- Sep 2016
- First submitted
- 5 Oct 2013
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37396307Li 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 33734135Li 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 31725459Deng 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT01962155
- Acronym / sponsor ID
- HBV / 2013ZX10002005
- Conditions
- Hepatitis B, Liver Fibrosis
- Keywords
- Fibrosis, Liver Cirrhosis, non-invasive, biopsy, hepatitis B virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,841 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic infected with hepatitis B virus | – | –patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients infected with hepatitis B virus for at least 6 months
Key inclusion criteria (3 listed)
- HBsAg positive for at least 6 months
- agree to have liver biopsy
- Male or female aged 18 to 65 years old
Key exclusion criteria (4 listed)
- Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
- platelet count < 80000/L
- prothrombin activity ≤ 60%
- patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Derived from this study: PubMed 37396307Li 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.
- Derived from this study: PubMed 33734135Li 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.
- Derived from this study: PubMed 31725459Li 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.
- Derived from this study: PubMed 28962551Deng 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.
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiqiang Wang principal investigator
Peking University First Hospital
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Liver Fibrosis, run by Peking University First Hospital at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962155, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.