Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- HBsAg positive rate in newborns
研究概览
简要总结
This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant HBsAg positive patients in prevention of HBV vertical transmission. Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery.
详细描述
Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery, which include HBeAg positive patients. Patients and their newborns were followed till 48 weeks after delivery to evaluate the efficacy of prevention of vertical transmission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive for more than 6 months
- •HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
- •HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
- •HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
- •HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
- •Nucleoside/nucleotide naive paitents
- •Diagnosed as ≥ 28 weeks pregnancy
排除标准
- •Diagnosed HCC with AFP and ultrasound, CT or MRI
- •Creatine >130μmol/L or Ccr < 70mL/min
- •Hemoglobin <100g/L
- •Coinfected with HAV,HEV,HCV,HDV or HIV
- •ANA > 1:100
- •Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
- •Drug abuse or alcohal addiction
- •Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
- •Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
- •Underwent liver transplantation or liver transplantation in schedule
- •Allergic to nucleoside or nucleotide analogues
- •family history of genetic defects disease
- •Abnormal results in fatal defects screening
- •HBsAg positive sperm provider pregnancy
研究组 & 干预措施
Chinese naive pregnant HBsAg positive patients
single group patients were enrolled to receive emtricitabine(200mg one time per day) till 24 weeks after dilivery,patients and followed up for 24 weeks.
干预措施: Emtricitabine (Drug)
结局指标
主要结局
HBsAg positive rate in newborns
时间窗: week48 after delivery
HBsAg positive rate in newborns
次要结局
- HBeAg seroconversion(week 24 after delivery)
- adverse event(week 24 after delivery)
- birth defect in newborns(0 weeks, week24 and week48 after delivery)
- virological response rate(week 24 after delivery)
- biochemical response(week 24 after delivery)
- HBV genetic resistance to emtricitabine(week 24 after delivery)
- HBV DNA decrease level(week 24 after delivery)
- HBeAg loss(week 24 after delivery)