Chronic hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients, 1 years to 12 years of age at baseline; 2.Positive HBsAg andHBeAg for more than 6 months; 3.Serum HBV DNA levels >1.0E+05copies/ml at screening; 4.Elevated serum ALT between 2 ULN and10 ULN for two times, andat least one month intervel.
Exclusion criteria
Exclusion criteria: 1.received antiviral therapy or immunosuppressant drugs within 6 months prior to enrollment; 2.Evidence of decompensated liver disease; 3.Presence of infection with HCV-RNA or anti-HCV, anti-HDV, or HIV at screening; 4.History of medical condition associated with chronic liver disease other than chronic hepatitis B; 5.History of significant renal, cardiovascular, pulmonary, neurological, autoimmune or bone disease; 6.History of a seizure disorder or current anticonvulsant use; 7.History of thyroid disease poorly controlled on prescribed medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function;HBV DNA;HBeAg;HBsAg; | — |
Countries
China