Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
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) in Chinese naive children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and 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 in children paitients. The investigators design this trial to test the effect of FTC in Chinese children CHB which including naive HBeAg positive and Negative CHB 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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with body weight ≥ 33 kg and who can swallow entire emtricitabine capsle(200mg)
- •HBsAg positive for more than 6 months
- •HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
- •HBeAg positive 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 positive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
- •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
- •Neutrophils <1.5E+9/L
- •PLT<80E+9/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
naive child CHB group
200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks
干预措施: Emtricitabine (Drug)
结局指标
主要结局
virological response rate
时间窗: week 48
HBV DNA \< 500 copies/ml
次要结局
- HBV DNA negativity rate(week 24)
- HBeAg reversion(week 24 and 48)
- HBsAg seroconversion(week 24 and 48)
- HBV DNA decrease level(week24 and 48)
- HBeAg seroconversion(week 24 and 48)
- HBsAg loss(week 24 and 48)
- adverse event(week 24 and 48)
- biochemical response(week 24 and 48)
- HBeAg loss(week 24 and 48)
- HBV genetic resistance to emtricitabine(week 24 and 48)
研究者
Jun Cheng
chaireman of Asian-Pacific Alliance of Liver Diseas,Beijing
Asian-Pacific Alliance of Liver Disease, Beijing