NCT02327702Unknown4 期
Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients
Asian-Pacific Alliance of Liver Disease, Beijing0 个研究点目标入组 200 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- virological response rate
研究概览
简要总结
This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.
详细描述
Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.
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
- Treatment
- 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 patients
- •Diagnosed as ≥ 12 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 chronice hepatitis B
Experimental
Chinese naive pregnant chronice hepatitis B were enrolled to take emtricitabine (200 mg one time per day) till 48 weeks after delivery.
干预措施: Emtricitabine (Drug)
结局指标
主要结局
virological response rate
时间窗: week 48 after delivery
HBV DNA \< 500 copies/ml
次要结局
- HBeAg loss(week 24 and 48 after delivery)
- HBsAg loss(week 24 and 48 after delivery)
- virological response rate(week 24 after delivery)
- HBV DNA decrease level(week 24 and 48 after delivery)
- biochemical response(week 24 and 48 after delivery)
- HBeAg reversion(week 24 and 48 after delivery)
- HBV genetic resistance to emtricitabine(week 24 and 48 after delivery)
- HBsAg seroconversion(week 24 and 48 after delivery)
- HBeAg seroconversion(week 24 and 48 after delivery)
- birth defect in newborns(0 weeks, week24 and week48 after delivery)
- adverse event(week 24 and 48 after delivery)
- HBsAg positive rate in newborns(0 weeks, week24 and week48 after delivery)
研究者
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