Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Child HBsAg 6 mo
研究概览
简要总结
To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.
详细描述
This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
treatment group
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
干预措施: Tenofovir Alafenamide (Drug)
结局指标
主要结局
Child HBsAg 6 mo
时间窗: 6 months after delivery
Serum status of HBsAg of the infants at 6 months old
次要结局
- Maternal renal(6 and 12 months post delivery)
- Materna bone marker(6 and 12 months post delivery)
- Children's growth(6 and 12 months after birth)
- Maternal HBeAg-seroconverion(12 months after delivery)
- Child HBsAg 12 mo(12 months after delivery)
- Maternal ALT elevation(6 months after delivery)