Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Liver indicators of intrapartum
研究概览
简要总结
The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.
详细描述
After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen University, the eligible patients were enrolled into the group.Each person will sign the informed consent prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •25 pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B were pregnant women at 24-28 weeks of pregnancy.
- •25 non-pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B.
- •The enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed.
排除标准
- •Coinfection with HAV, HCV, HDV, HEV or HIV;
- •A history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids;
- •Three-dimensional ultrasonography showed fetal malformation;
- •The spouse is infected with HBV;
- •History of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms;
- •History of immune diseases;
- •A history of serious cardiovascular disease;
- •Other reasons the researchers considered it inappropriate to participate in the trial.
研究组 & 干预措施
Pregnant women with CHB
Start taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected.
干预措施: Tenofovir Alafenamide 25 MG (Drug)
women with CHB
Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens.
干预措施: Tenofovir Alafenamide 25 MG (Drug)
结局指标
主要结局
Liver indicators of intrapartum
时间窗: intrapartum
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.
Liver indicators of postpartum
时间窗: 12 months postpartum
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women 1 month、3 month、7 month、9 month、12 month after delivery.
次要结局
- Liver indicators of pregnancy(24 weeks gestation until delivery)
研究者
Chaoshuang Lin
Professor Lin
Third Affiliated Hospital, Sun Yat-Sen University