Chronic Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: positive reading for hepatitis B surface antigen (HBsAg) for at least 6 months; positive reading for hepatitis E antigen (HBeAg); serum HBV DNA load above 109 copies/ml at baseline; had ALT levels between 2 and 10 times the upper normal level (UNL) and meeting the general indications for antiviral therapy, as recommended by the Chinese Society of Hepatology
Exclusion criteria
Exclusion criteria: presence of serum antibodies against hepatitis C virus (HCV), hepatitis A virus, hepatitis E virus, or human immunodeficiency virus (HIV); breastfeeding, pregnancy, or inadequate contraceptive measures; substance abuse in the previous 2 years; other acquired or inherited causes of liver disease; serious concomitant disease; and advanced liver disease (including decompensated cirrhosis with ascites, severe hepatitis, and hepatic carcinoma).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA;ALT;HBeAg; | — |
Secondary
| Measure | Time frame |
|---|---|
| Resistance;Safety; | — |
Countries
China