CHB
Conditions
Interventions
Treatment:LAM (4mg/kg/d) before 1 year of age, and after 1 year of age if still positive for HBV DNA and/or HBsAg, then combined with regular interferon (intramuscular or subcutaneous, 3-6 million U/m
Control:Follow-up and observation
Sponsors
General Hospital of the Chinese PLA
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: a. Age = 1 year; b. HBsAg and HBV DNA positive; c. ALT = 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months). d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.
Exclusion criteria
Exclusion criteria: a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc; b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease; c. WBC <9 × 10^9/L, or PLT <90 × 10^9/L; d. Combination of other systemic serious diseases or hereditary diseases, etc; e. Other conditions deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of HBsAg loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of HBV DNA loss;The rate of HBsAg seroconversion;The rate of HBeAg loss;The rate of HBeAg seroconversion;ALT reversion rate; | — |
Countries
China
Contacts
Public ContactJunliang Fu
the Fifth Medical Center of PLA General Hospital
Outcome results
None listed