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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the antiviral group | Experimental | HBV-infected infants in the treatment group were treated with LAM (4 mg/kg/d) before 1 year of age, and then combined with regular interferon (intramuscular or subcutaneous injection, 3-6 million U/m2 body surface area, every other day, with a starting dose of 3 million U/m2 body surface area, which was adjusted according to the specific tolerances of the children during the course of the treatment) if they were still HBV DNA and/or HBsAg-positive at the end of the 1st year of age. The course of interferon treatment is 52 weeks. |
|
| the control group | No Intervention | synchronized follow-up visits without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine | Drug | 4mg/kg/d, oral |
| |
| Interferon |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of HBsAg loss | The rate of HBsAg loss in 12months after intervention, 2 years old | 12months after intervention, 2 years old |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of HBsAg seroconversion | The rate of HBsAg seroconversion in 12months after intervention, 2 years old | 12months after intervention, 2 years old |
| The rate of HBV DNA loss | The rate of HBV DNA loss in 12months after intervention, 2 years old |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junliang Fu, PhD, MD | Contact | 86-10-66933214 | fjunliang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junliang Fu | The fifth medical center of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Fifth Medical Center of PLA | Beijing | China |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| D007372 | Interferons |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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the antiviral group and the control group
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| Drug |
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. |
|
| 12months after intervention, 2 years old |
| The rate of HBeAg loss | The rate of HBeAg loss in 12months after intervention, 2 years old | 12months after intervention, 2 years old |
| The rate of HBeAg seroconversion | The rate of HBeAg seroconversion in 12months after intervention, 2 years old | 12months after intervention, 2 years old |
| ALT reversion rate | ALT reversion rate in 12months after intervention, 2 years old | 12months after intervention, 2 years old |
| Incidence of Treatment-Emergent Adverse Events | Safety and Tolerability of Antiviral Therapy in infants | 12months after intervention, 2 years old |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |