Chronic hepatitis B virus infection
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, 3 to 12 years of age; 2. detection of HBsAg and HBeAg in serum for longer than 6 months prior to baseline visit; 3. Serum HBV DNA levels more than 1.0E+07 IU/mL; 4. ALT less than 40IU/L; 5. Absolute neutrophil count more than 1.5 G/L and platelet count more than 120 G/L; 6. Creatinine clearance more than 80 mL/min; 7. Anti-HBV na?ve children.
Exclusion criteria
Exclusion criteria: 1. Presence of infection with HCV-RNA or anti-HCV, anti-HDV, or HIV at screening; 2. Evidence of active liver disease; 3. History of significant renal, cardiovascular, pulmonary, neurological, autoimmune or bone disease; 4. History of a seizure disorder or current anticonvulsant use; 5. History of thyroid disease poorly controlled on prescribed medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA;HBeAg;HBsAg; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function; | — |
Countries
China