Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 主要终点
- The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
研究概览
简要总结
To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.
详细描述
Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml
排除标准
- •co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB
研究组 & 干预措施
Lamivudine
lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants
干预措施: Lamivudine (Drug)
Telbivudine
Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants
干预措施: Telbivudine (Drug)
结局指标
主要结局
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
时间窗: perinatal to 28 weeks after infant delivery
Its efficacy in the reduction of HBV vertical transmission rate
时间窗: perinatal to 28 weeks after infant delivery
次要结局
- Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg(perinatal to 28 weeks of postpartum)
研究者
Hua Zhang
Professor
Beijing YouAn Hospital