NCT02287857Unknown不适用
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 15
- 主要终点
- Compared with baseline, decline of serum HBV-DNA in the value
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B
- •Aged 18 to 65 years old，male or female
- •Patients with previously HBsAg-positive lasted for 6months at least：HBeAg-positive subjects, HBV-DNA> 105copies/ml； HBeAg-negative subjects, HBV-DNA> 104copies/ml.
- •2 times the upper normal limit (2 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
- •Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
- •Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
- •WBC ≥ 3.5 × 109 / L, PLT ≥ 80 × 109 / L, serum albumin (ALB)≥ 35 g / L.
- •Creatinine (Cr) ≤ 1× ULN，serum phosphate was normal.
- •Patients signed an informed consent form and compliance was good.
排除标准
- •Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.
- •Patients with cirrhosis or liver cancer.
- •Pregnant woman, lactating women .
- •Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
- •Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
- •Patients allergic for study drug.
研究组 & 干预措施
Domestic Tenofovir Disoproxil Fumarate Tablets
Experimental
干预措施: Domestic Tenofovir Disoproxil Fumarate Tablets (Drug)
Tenofovir Disoproxil Fumarate Tablets of Gilead
Active Comparator
干预措施: Tenofovir Disoproxil Fumarate Tablets of Gilead (Drug)
结局指标
主要结局
Compared with baseline, decline of serum HBV-DNA in the value
时间窗: 48 week
次要结局
未报告次要终点
研究者
研究点 (15)
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