Antiviral Therapy in Infants With HBV Infection
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of HBsAg loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
the antiviral group
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.
干预措施: Lamivudine (Drug)
the antiviral group
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.
干预措施: Interferon (Drug)
结局指标
主要结局
The rate of HBsAg loss
时间窗: 12months after intervention, 2 years old
The rate of HBsAg loss in 12months after intervention, 2 years old
次要结局
- The rate of HBeAg seroconversion(12months after intervention, 2 years old)
- ALT reversion rate(12months after intervention, 2 years old)
- The rate of HBsAg seroconversion(12months after intervention, 2 years old)
- The rate of HBV DNA loss(12months after intervention, 2 years old)
- The rate of HBeAg loss(12months after intervention, 2 years old)
- Incidence of Treatment-Emergent Adverse Events(12months after intervention, 2 years old)