HBV
Conditions
Brief summary
This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and/or HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.
Interventions
DRUGLamivudine
4mg/kg/d, oral
DRUGInterferon
Use only in children who remain positive for HBV-DNA and/or HBsAg after 1 year of age. Regular interferon (3 million U/m2 body surface area, intramuscular or subcutaneous, every other day, adjusted during treatment according to the child's specific tolerance) for 52 weeks.
Sponsors
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
the antiviral group and the control group
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| The rate of HBsAg loss | 12months after intervention, 2 years old | The rate of HBsAg loss in 12months after intervention, 2 years old |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of HBV DNA loss | 12months after intervention, 2 years old | The rate of HBV DNA loss in 12months after intervention, 2 years old |
| The rate of HBeAg loss | 12months after intervention, 2 years old | The rate of HBeAg loss in 12months after intervention, 2 years old |
| The rate of HBsAg seroconversion | 12months after intervention, 2 years old | The rate of HBsAg seroconversion in 12months after intervention, 2 years old |
| ALT reversion rate | 12months after intervention, 2 years old | ALT reversion rate in 12months after intervention, 2 years old |
| Incidence of Treatment-Emergent Adverse Events | 12months after intervention, 2 years old | Safety and Tolerability of Antiviral Therapy in infants |
| The rate of HBeAg seroconversion | 12months after intervention, 2 years old | The rate of HBeAg seroconversion in 12months after intervention, 2 years old |
Countries
China
Contacts
Primary ContactJunliang Fu, PhD, MD
Outcome results
None listed