Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 2,000
- 主要终点
- virological response rate
研究概览
简要总结
This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.
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. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these 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
- •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
排除标准
- •Diagnosed HCC with AFP and ultrasound, CT or MRI
- •Creatine >130μmol/L or Ccr < 70mL/min
- •Hemoglobin <100g/L
- •Neutrophils <1.5E+9/L
- •PLT<80E+9/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
- •Preganency or in breastfeeding
研究组 & 干预措施
HBeAg positive CHB group
1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined
干预措施: Emtricitabine (Drug)
HBeAg negativie CHB group
1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined
干预措施: Emtricitabine (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
- biochemical response(week 24,48,72 and 96)
- HBeAg loss(week 24,48,72 and 96)
- HBeAg reversion(week 24,48,72 and 96)
- HBV DNA decrease level(week24, 48, 72 and 96)
- HBV DNA negativity rate(week 24, 48 and 72)
- HBsAg loss(week 24,48,72 and 96)
- HBeAg seroconversion(week 24,48,72 and 96)
- HBsAg seroconversion(week 24,48,72 and 96)
- adverse event(week 24,48,72 and 96)
- HBV genetic resistance to emtricitabine and adefovir(week 24,48,72 and 96)
研究者
Jun Cheng
chaireman of Asian-Pacific Alliance of Liver Diseas,Beijing
Asian-Pacific Alliance of Liver Disease, Beijing