"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatitis B， Chronic. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
"Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu
Overview
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.
Primary outcome measures
- 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]
- Hepatocellular carcinoma (HCC) [Time frame: 20 years]
- Death [Time frame: 20 years]
Eligibility criteria
Inclusion criteria
- Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 6 centers
- The Third Hospital of Changzhou — Changzhou
- Huai'an No.4 People's Hospital — Huai'an
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing
- Nanjing Jiangbei People's Hospital — Nanjing
- Suqian People's Hospital — Suqian
- The Fifth People's Hospital of Suzhou — Suzhou
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. PMID 38835029
- Yao 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. PMID 37742745
- Wang 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. PMID 36317959
Identifiers
NCT: NCT03097952 · NJDTID-001