Chronic Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. History of Hepatitis B or HBsAg positive for more than 6 months, HBsAg and HBV DNA positive currently; 2. Who have not received antiviral therapy including nucleoside (acid) analogues (NAs) and interferon; 3. HBV DNA >20000 IU/ml; 4. alanine aminotransferase (ALT) >= 2 upper limit of normal (ULN) and =4 or >=G2 inflammation or >= S2 fibrosis on the liver biopsy.
Exclusion criteria
Exclusion criteria: 1. With history of antiviral therapy; 2. Co-infection with HCV, HDV, and HIV; 3. Who have liver disease caused by other reasons including autoimmune hepatitis, drug-induced hepatitis or alcoholic hepatitis; 4. NEUT < 1.0×10^9/L or PLT <50×10^9/L; 5. Decompensated cirrhosis; 6. Severe thyroid dysfunction; 7. Retinal disease, heart failure, chronic obstructive pulmonary disease; 8. pregnancy, mental illness(history of schizophrenia or major depressive disorde ), history of drug or alcohol abuse; uncontrolled seizure disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg;HBV DNA;HBeAg;MxA mRNA;HIF-1a mRNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT;USPl8 mRNA; | — |
Countries
China
Contacts
Wenzhou Medical University