Hepatitis B， ChronicNCT03097952
"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu
An observational study of Hepatitis B， Chronic, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 6 sites in China.
Trial summary
Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B， Chronic
- How many people
- 20,000 participants
- Where
- 6 sitesChina
- Study dates
- Jan 2008to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients chronically infected with hepatitis B virus
Who may be able to join
- Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)
Who cannot join
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
- History of liver transplantation
- History of hepatocellular carcinoma (HCC)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rui Huang, M.D., Ph.D. contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The Third Hospital of Changzhou
Changzhou, Jiangsu, 213001
Longgen Liu
- Recruiting
Huai'an No.4 People's Hospital
Huai'an, Jiangsu, 223300
Biao Zhang
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Chao Wu, M.D., Ph.D., 86-25-83105890, dr.wu@nju.edu.cn
Rui Huang, M.D., Ph.D., doctor_hr@126.com
- Recruiting
Nanjing Jiangbei People's Hospital
Nanjing, Jiangsu, 210048
Jie Yin
- Recruiting
Suqian People's Hospital
Suqian, Jiangsu, 223800
Huaping Shao
- Recruiting
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, 215007
Chuanwu Zhu
About this study
Official title: "Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu
Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.
- Conditions
- Hepatitis B， Chronic
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with antigen loss (HBeAg and HBsAg loss)
Measured: 20 years
Cirrhosis
Measured: 20 years
Hepatic decompensation
Development of hepatic decompensation will be defined by any of the following events:
(1) Ascites or hepatic hydrothorax; (2)Variceal or portal hypertensive bleeding; (3)Hepatic encephalopathy
Measured: 20 years
Hepatocellular carcinoma (HCC)
The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Measured: 20 years
Death
Date and cause of death will be recorded.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startJan 2008
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B， ChronicStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 20,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097952
- Sponsor's protocol ID
- NJDTID-001
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
Publications
Wang J, Zhu L, Zhang Z, Zhang S, Pan Y, Li Y, Cao F, Jiang C, Fan T, Xiong Y, Liu J, Chen Y, Yin S, Tong X, Zhu C, Liu X, Li J, Wu C, Huang R. Lower HBV DNA level is associated with more severe liver fibrosis in HBeAg-positive chronic hepatitis B with normal alanine transaminase. Virol J. 2024 Jun 4;21(1):127. doi: 10.1186/s12985-024-02368-0.
PubMed 38835029Yao R, Lu S, Xue R, Wang J, Qiu Y, Chen Y, Liu J, Zhu L, Zhan J, Jiang S, Yin S, Tong X, Ding W, Li J, Zhu C, Huang R, Wu C. NAFLD is associated with less severe liver fibrosis in chronic hepatitis B: A multi-center, retrospective study. Ann Hepatol. 2024 Jan-Feb;29(1):101155. doi: 10.1016/j.aohep.2023.101155. Epub 2023 Sep 24.
PubMed 37742745Wang J, Liu J, Liu Y, Xue R, Zhan J, Jiang S, Wang L, Yan X, Xiong Y, Xia J, Yin S, Tong X, Chen Y, Li J, Huang R, Wu C. Clinical features of chronic hepatitis B patients with lean nonalcoholic fatty liver disease. Hepatol Res. 2023 Mar;53(3):184-195. doi: 10.1111/hepr.13854. Epub 2022 Nov 21.
PubMed 36317959
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu
- ClinicalTrials.gov ID
- NCT03097952
- Acronym / sponsor ID
- NJDTID-001
- Conditions
- Hepatitis B， Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 31 Mar 2017 (actual)
- 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.
Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients chronically infected with hepatitis B virus
Key inclusion criteria (1 listed)
- Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)
Key exclusion criteria (3 listed)
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
- History of liver transplantation
- History of hepatocellular carcinoma (HCC)
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
Number of participants with antigen loss (HBeAg and HBsAg loss)
Time frame: 20 years
Cirrhosis
Time frame: 20 years
Hepatic decompensation
Time frame: 20 years
Development of hepatic decompensation will be defined by any of the following events: (1) Ascites or hepatic hydrothorax; (2)Variceal or portal hypertensive bleeding; (3)Hepatic encephalopathy
Hepatocellular carcinoma (HCC)
Time frame: 20 years
The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Death
Time frame: 20 years
Date and cause of death will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Derived from this study: PubMed 38835029Wang J, Zhu L, Zhang Z, Zhang S, Pan Y, Li Y, Cao F, Jiang C, Fan T, Xiong Y, Liu J, Chen Y, Yin S, Tong X, Zhu C, Liu X, Li J, Wu C, Huang R. Lower HBV DNA level is associated with more severe liver fibrosis in HBeAg-positive chronic hepatitis B with normal alanine transaminase. Virol J. 2024 Jun 4;21(1):127. doi: 10.1186/s12985-024-02368-0.
- Derived from this study: PubMed 37742745Yao R, Lu S, Xue R, Wang J, Qiu Y, Chen Y, Liu J, Zhu L, Zhan J, Jiang S, Yin S, Tong X, Ding W, Li J, Zhu C, Huang R, Wu C. NAFLD is associated with less severe liver fibrosis in chronic hepatitis B: A multi-center, retrospective study. Ann Hepatol. 2024 Jan-Feb;29(1):101155. doi: 10.1016/j.aohep.2023.101155. Epub 2023 Sep 24.
- Derived from this study: PubMed 36317959Wang J, Liu J, Liu Y, Xue R, Zhan J, Jiang S, Wang L, Yan X, Xiong Y, Xia J, Yin S, Tong X, Chen Y, Li J, Huang R, Wu C. Clinical features of chronic hepatitis B patients with lean nonalcoholic fatty liver disease. Hepatol Res. 2023 Mar;53(3):184-195. doi: 10.1111/hepr.13854. Epub 2022 Nov 21.
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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.
Rui Huang, M.D., Ph.D. contact
6 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， Chronic, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 6 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Wu, M.D., Ph.D (86-25-83105890, dr.wu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with antigen loss (HBeAg and HBsAg loss) (time frame: 20 years). The study lists 5 primary outcomes in all. 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 NCT03097952, which also lists 3 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 31 Mar 2017.