Chronic Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: According to the EASL clinical practice guidelines: Management of chronic hepatitis B virus infection and the Chinese guideline of prevention and treatment for chronic hepatitis B: a 2015 update ,the inclusion criteria were determined: 1. more than six months of a history of hepatitis B or HBsAg positive; 2. HBV DNA positive (=2000 IU/mL); 3. continuous or repeated abnormal of ALT or inflammation of liver tissue; 4. aged 15 to 67 years.
Exclusion criteria
Exclusion criteria: 1. liver cirrhosis or liver cancer confirmed by clinical diagnosis; 2. high level of TBIL (=150umol/L)or liver failure; 3. Complicated with metabolic diseases or autoimmune liver diseases; 4. co-infected with HIV, HCV and HDV; 5. abused alcohol or illegal drugs, or participated in other drug trials within 30 days; 6. With a history of using nucleoside analogues, interferon, immune modulators and other anti-hepatic fibrosis drugs within 24 weeks; 7. receiving the treatment of anti-inflammatory and protect liver or taking related drugs such as glycyrrhizin and so on; 8. mental diseases or other serious viscera diseases; 9. pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT;AST;TBIL;HBeAg;HBV DNA;APRI;FibroScan (Kpa);hepatic pathology (G, S);The degree of fatty liver;FibroScan (IQR/M);the number of liver portal area;PLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| age;gender; | — |
Countries
China
Contacts
Foshan Hospital of Traditional Chinese Medicine