Observational study on chronic Hepatitis B infection in Jiangsu
"Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu
This study is collecting information from people with chronic Hepatitis B in Jiangsu, China, to see what factors might affect their health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 6 sites (Changzhou, Jiangsu and 5 other locations) |
| Trial ID | NCT03097952 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to gather data from non-selected patients with chronic Hepatitis B virus (HBV) infection in Jiangsu, China. The study will create a comprehensive database that includes epidemiological, clinical, biological, virological, immunologic, and therapeutic parameters. By analyzing these factors, the researchers hope to identify predictors of outcomes in patients suffering from chronic HBV infection, which remains a significant health concern worldwide.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have been diagnosed with chronic HBV infection, defined as being HBsAg positive for at least six months.
Not a fit: Patients with co-infections such as HIV, HCV, or HDV, as well as those with a history of liver transplantation or hepatocellular carcinoma, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of chronic HBV infection, potentially reducing the risk of severe outcomes such as cirrhosis and liver cancer.
How similar studies have performed: While there have been various studies on chronic HBV infection, this particular observational approach focusing on a non-selected cohort in Jiangsu is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Changzhou, Jiangsu and 5 other locations
- The Third Hospital of Changzhou — Changzhou, Jiangsu, China (Recruiting)
- Huai'an No.4 People's Hospital — Huai'an, Jiangsu, China (Recruiting)
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
- Nanjing Jiangbei People's Hospital — Nanjing, Jiangsu, China (Recruiting)
- Suqian People's Hospital — Suqian, Jiangsu, China (Recruiting)
- The Fifth People's Hospital of Suzhou — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Chao Wu, M.D., Ph.D
- Email: dr.wu@nju.edu.cn
- Phone: 86-25-83105890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.