A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
研究概览
简要总结
500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml
排除标准
- •pregnancy patients with HBeAg-negative or HBV-DNA<106copies /ml
研究组 & 干预措施
Tenofovir1
100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery.
干预措施: Tenofovir1 (Drug)
Tenofovir2
100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery.
干预措施: Tenofovir2 (Drug)
Tenofovir3
100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery.
干预措施: Tenofovir3 (Drug)
Tenofovir4
100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery.
干预措施: Tenofovir4 (Drug)
结局指标
主要结局
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
时间窗: up to 1 year
Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL
次要结局
- interferon-γ (IFN-γ)(up to 1 year)
- Interleukin 6 (IL-6)(up to 1 year)
- T cell ratio(up to 1 year)
- Interleukin 4 (IL-4)(up to 1 year)
- hepatitis B e-antigen (HBeAg)(up to 1 year)
- HBV-DNA in placenta tissue(the date of delivery)
- the concentration of Interleukin 2 (IL-2)(up to 1 year)
- HBV-DNA of babies(when the baby is 7-month-old)