Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 主要终点
- virological response rate
研究概览
简要总结
This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.
详细描述
Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dignosed cirrhosis patients
- •HBsAg positive for more than 6 months
- •HBV DNA detectable
- •Nucleoside/nucleotide naive patients
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 cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer;
- •Drug abuse or alcohol 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
- •Pregnancy or in breastfeeding
研究组 & 干预措施
compensated HBV related cirrhosis patients
Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks
干预措施: Emtricitabine plus adefovir dipivoxil (Drug)
decompensated HBV related cirrhosis patients
Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks
干预措施: Emtricitabine plus adefovir dipivoxil (Drug)
结局指标
主要结局
virological response rate
时间窗: week 96
HBV DNA \< 500 copies/ml
次要结局
- HBV DNA negativity rate(week 24, 48 and 72)
- HBV DNA decrease level(week24, 48, 72 and 96)
- biochemical response(week 24,48,72 and 96)
- HBeAg loss(week 24,48,72 and 96)
- HBeAg seroconversion(week 24,48,72 and 96)
- HBeAg reversion(week 24,48,72 and 96)
- change of MELD score and Child-Pugh score(week 24,48,72 and 96)
- HBsAg loss(week 24,48,72 and 96)
- HBsAg seroconversion(week 24,48,72 and 96)
- HBV genetic resistance to emtricitabine and adefovir(week 24,48,72 and 96)
- adverse event(week 24,48,72 and 96)
- incidence of HCC(week 24,48,72 and 96)