NCT02967939已完成3 期
Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802(Tenofovir Disoproxil Orotate) and Viread®(Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Difference of HBV DNA level(log10)
研究概览
简要总结
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients
详细描述
- DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks.
- Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with chronic hepatitis B aged 18 years or older
- •Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit
- •Subjects who have HBsAg positive test at screening visit
- •Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test
- •Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening
排除标准
- •Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus
- •Subjects with creatinine clearance of less than 50 ml/min at the screening visit
- •At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma
- •Subjects with decompensated liver disease who meet the following criteria:
- •Total bilirubin levels greater than 2.5 mg/dl
- •Prothrombin time is at least 3 seconds longer than normal upper limit
- •Serum albumin value less than 30 g/l
- •Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.
研究组 & 干预措施
DA-2802
Experimental
DA-2802 319mg tablet qd
干预措施: DA-2802 (Drug)
Viread®
Active Comparator
Viread® 300mg tablet qd
干预措施: Viread® (Drug)
结局指标
主要结局
Difference of HBV DNA level(log10)
时间窗: Change from baseline at 48 weeks
次要结局
- Percentage of subjects who experienced loss of HBeAg(at 24 week, 48 week)
- Percentage of subjects HBV DNA < 400 copies/ml(at 24 weeks, 48 weeks)
- Percentage of subjects who had normal ALT levels(at 24 week, 48 week)
研究者
研究点 (1)
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