Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 3
- 主要终点
- HBV serologic markers and alanine transaminase (ALT) levels in infants
研究概览
简要总结
Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen (HBeAg) have an increased risk of becoming infected with HBV. This study will determine whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.
详细描述
Infants of HBV-infected mothers with positive HBeAg have an increased risk of becoming infected with HBV. Standard immunoprophylaxis against mother-to-infant transmission of HBV includes administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine; however, approximately 5-15% of the infants are not protected despite having received these preventive measures. It is reported that antiviral prophylaxis among HBV-infected pregnant women can reduce mother-to-infant transmission of HBV. However, more research is needed to obtain the definite conclusion. This study will determine whether telbivudine among HBsAg- and HBeAg-positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.
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
- •pregnant women at 28-32 weeks of gestation
- •both HBsAg and HBeAg positive
- •good compliance
排除标准
- •Coinfection of HAV, HCV, HEV, HIV, and STD
- •With history of antiviral treatment against HBV
- •With chronic disease, such as heart and kidney disease, asthma, diabetes, hyperthyroidism, severe anemia, bleeding disease, autoimmune diseases
- •With threatened miscarriage or relevant treatment during the pregnancy
- •With pregnant complications such as pregnancy hypertension, preeclampsia, etc
- •With history of fetal deformity, or fetal deformity detected by ultrasound examination
- •With ALT >10 times upper limit, or total bilirubin >3 times upper limit, of normal value
研究组 & 干预措施
Telbivudine
HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation start to orally take telbivudine (600 mg/day) until 4 weeks after delivery. Newborn infants receive standard immunoprophylaxis.
干预措施: Telbivudine (Drug)
结局指标
主要结局
HBV serologic markers and alanine transaminase (ALT) levels in infants
时间窗: 10 months after birth
HBsAg and HBeAg are tested in umbilical blood and peripheral blood collected at the age of 10 months respectively. ALT is measured at 10 months old.
次要结局
- Women and infants with adverse events(Up to 10 months after delivery/birth)
- HBV DNA quantification and ALT levels in mothers(Up to 10 months postpartum)
研究者
Yi-Hua Zhou
Professor of Infectious Diseases, Chair of Experimental Medicine
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School