An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- HBV DNA load in serum
研究概览
简要总结
To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.
详细描述
Tenofovir Disoproxil Fumarate is a American Food and Drug Administration (FDA) pregnancy class B drug. To determine the optimal time for the tenofovir treatment during the pregnancy among women with chronic HBV infection and high HBV DNA load. Pregnant women with high HBV DNA load and normal liver function at second trimester will be randomized into three treatment groups at the 20th week of gestation and treated with tenofovir from 24 weeks, 28 weeks and 32 weeks to 1 month postpartum, respectively. The blood will be drawn at 24 weeks, 28 weeks, 32 weeks, 36 weeks and the delivery, respectively and the HBV DNA load and liver functions will be tested. The status of HBV infection for infants will be observed at 1st month, 7th month and 12th month after the babies were delivered. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants and safety outcomes will be compared across the three groups.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 20 and 40 years old
- •Have had HBsAg positive in serum greater than 6 months
- •HBV DNA load>10**6 IU/ml
- •Gestation week<24 weeks
- •Normal liver function
- •Able to comprehend and willing to sign the informed consent form
排除标准
- •Combined with following infections: hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and human immunodeficiency virus (HIV)
- •Got antiviral treatments before 24 weeks of Gestation
- •Got immunosuppressor treatment and/or steroids
- •Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B
- •Got serious obstetric complications
- •Got evidence of fetal deformity diagnosed by four-dimensional color Doppler ultrasound examination
- •Biological father of infant had HBV infection
研究组 & 干预措施
Tenofovir 24 week
Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 24 weeks of gestation to 1 month postpartum
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Tenofovir 28 week
Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 28 weeks of gestation to 1 month postpartum
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Tenofovir 32 week
Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 32 weeks of gestation to 1 month postpartum
干预措施: Tenofovir Disoproxil Fumarate (Drug)
结局指标
主要结局
HBV DNA load in serum
时间窗: 40 weeks, from randomization to delivery
the difference in the percentage of mothers whose HBV DNA load in serum are less than 10\*2 IU/ml at delivery among the groups
次要结局
- Intrauterine HBV infection rate of infants(12 months, from delivery to one-year birth date)
- Change in HBV DNA load(40 weeks, from randomization to delivery)
- Change in hepatitis B e antigen (HBeAg) titer(40 weeks, from randomization to delivery)