Chronic Hepatitis B Clinical Trial
Official title:
A Retrospective-prospective Observational Study to Evaluate the Effect of Anti-viral Treatment on the Long-term Outcome in Patients With Chronic Hepatitis B (SEARCH-B Study)
| NCT number | NCT02167503 |
| Other study ID # | MOH-08 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | June 17, 2014 |
| Last updated | June 17, 2014 |
| Start date | May 2014 |
The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.
| Status | Recruiting |
| Enrollment | 10000 |
| Est. completion date | |
| Est. primary completion date | May 2020 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years and older |
| Eligibility |
Inclusion Criteria: - Male or female, aged over 30 (inclusive) years of old - Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months) - For patients with HBsAg positive, patients should be undergoing anti-viral treatment - For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided. - Life expectancy is more than 1 year - Good treatment compliance. Exclusion Criteria: - Patients has a history of diagnosis of hepatocellular carcinoma - Patients with Child Pugh C - Coinfected with HCV, HDV and HIV - Suffering from other serious disease - Taking part in other clinical trial |
Observational Model: Cohort
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Ditan Hospital | Beijing | Beijing |
| China | Beijing Friendship Hospital Attached to the Capital Medical University | Beijing | Beijing |
| China | BeiJing YouAn Hospital ,Capital Medical University | BeiJing | Beijing |
| China | Department of infectious disease, First Hospital of Peking University | Beijing | Beijing |
| China | People's Hospital of Beijing University | Beijing | Beijing |
| China | First Hospital .Jilin Unniversity | ChangChun | Jilin |
| China | Xiangya Hospital Central-South Univrsity | ChangSha | Hunan |
| China | Department of infectious disease, Nanfang Hospital | Guangzhou | Guangdong |
| China | The Third Hospital of Sun Yat-Sen University | GuangZhou | Guangdong |
| China | The First Affiliated Hospital of College of Medicine ,Zhejiang University | HangZhou | Zhejiang |
| China | Huashan Hospital,Fudan University | ShangHai | Shanghai |
| China | Shanghai Ruijin Hospital | ShangHai | Shanghai |
| China | ShengJing Hospital of China Medical University | ShenYang | Liaoning |
| China | Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei |
| Lead Sponsor | Collaborator |
|---|---|
| Nanfang Hospital of Southern Medical University | National Health and Family Planning Commission, P.R.China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cumulative rates of hepatocellular carcinoma | Year 5 | No |
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