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This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.
Chronic viral hepatitis is defined as infectious liver disease caused by persistent virus infection for more than six months. Sustained viral replication and ongoing liver inflammation can eventually lead to liver fibrosis/cirrhosis or even hepatocellular carcinoma. Chronic viral hepatitis infection causes at least 80% of all liver cancers.
Though chronic viral hepatitis is a major global health concern, there is still a lack of evidence in high quality about the management of chronic viral hepatitis and the long-term outcome of patients. The concept of real-world data and research has been officially introduced into China since 2010. Real-world evidence, based on real-world data, can help practitioners have better understanding of the characteristics of the patients with different treatment strategies.
This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronic hepatitis B | No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed. | ||
| chronic hepatitis C | No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Virologic responses(for both chronic hepatitis B and C) | Sustained virological response (Able to sustain an undetectable viral load for a period) | 24 weeks after treatment initiation |
| Serological responses(for chronic hepatitis B only) | Hepatitis B e antigen (HBeAg) seroconversion(HBeAg loss and presence of anti-HBe) and hepatitis B surface antigen(HBsAg) seroconversion (HBsAg loss and presence of anti-HBs) | 48 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Histological responses(for both chronic hepatitis B and C) | Significant improvement in fibrosis was defined as a decrease in the Ishak score of at least 1 point; (the Ishak score describes six stages of fibrosis, 0 for No fibrosis and 6 for Cirrhosis; higher the Ishak score is, more severe the fibrosis is). | 48 weeks after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
Serious psychiatric history, especially depression.
Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
Patients with malignant tumors (excluding those cured).
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Patients with chronic viral hepatitis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiqi Yu, Doctor | Contact | 13601637563 | 02152887969 | yyq19890619@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenhong Zhang, Professor | Huashan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29388206 | Background | Maucort-Boulch D, de Martel C, Franceschi S, Plummer M. Fraction and incidence of liver cancer attributable to hepatitis B and C viruses worldwide. Int J Cancer. 2018 Jun 15;142(12):2471-2477. doi: 10.1002/ijc.31280. Epub 2018 Feb 9. | |
| 29599078 | Background | Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):383-403. doi: 10.1016/S2468-1253(18)30056-6. Epub 2018 Mar 27. |
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| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |