A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 主要终点
- the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
详细描述
In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20-40 years old pregnant woman with gestational age of 20-32 week;
- •positive serum HBsAg;
- •HBV DNA≥1.0x106 copies/ml;
排除标准
- •with previous antiviral treatment;
- •with clinical sign of threatened miscarriage or related treatment in early pregnancy;
- •positive serum HAV, HCV, HDV and HEV tests;
- •fetus deformity by 3-D ultrasound examination;
- •on other dugs, such as immune modulators, cytotoxic drugs or steroids;
- •husbands are infected with HBV.
研究组 & 干预措施
Telbivudine
Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
干预措施: Telbivudine (Drug)
Control
The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
干预措施: engineered HB vaccine (Biological)
结局指标
主要结局
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
时间窗: 1 month post partum
次要结局
- liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;(1 month post partum)
- drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence(.1 year after childbirth)