NCT02805738Unknown3 期
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet and Viread® Tablet in Chronic Hepatitis B Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 158
- 试验地点
- 20
- 主要终点
- The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet
详细描述
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis B Patients Subjects will receive either a single oral dose of the test formulation(CKD-390) or a oral dose of the reference formulation(viread).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female older than 19 years at the time of screening
- •Patients who have chronic hepatitis B disease are taken Viried for 6 months
- •Patients who show HBV DNA undetected(less than 20 IU/mL)
- •Patients who show positive HBsAg
- •Patients who show positive HBeAg or negative HBeAg
- •Patients who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent
排除标准
- •Patients who are not taken any anti-viral agents except Viread Tab
- •Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
- •Patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhage or Patients with following value at screening
- •total bilirubin > Upper normal limit x 1.5
- •prothrombin time(INR) > Upper normal limit x 1.5
- •platelets < 75,000/ul
- •serum albumin < 3.0g/dl
- •Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL
- •Patients who show Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
- •Patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study
- •Patients who have other hepatic diseases like hematochromatosis, Wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome
- •Patients with genetic disease like Galactose intolerance, lapplactase deficiency, Glucose-galactose malabsorption
- •History of malignant tumor within 5 years
- •Patients who take any other investigational product within 30 days
- •Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
- •Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- •Patients who receive an organ transplant or bone marrow transplant or are going to received surgury
- •History of allergic reaction to the investigational product
- •Patients that investigators consider ineligible for this study
研究组 & 干预措施
Experimental Group
Experimental
once a time per a day, CKD-390 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks
干预措施: CKD-390 (Drug)
Active comparator Group
Active Comparator
once a time per a day, Viread 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks
干预措施: viread (Drug)
结局指标
主要结局
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
时间窗: 24weeks after drug administration
次要结局
- The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)(12, 36, 48 weeks after drug administration)
- The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level(12, 24, 36, 48 weeks after drug administration)
- The rate of subjects who had normal ALT result(12, 24, 36, 48weeks after drug administration)
- The rate of subjects who showed HBeAg loss(24, 48 weeks after drug administration)
- The rate of subjects who showed HBeAg seroconversion(24, 48 weeks after drug administration)
- The rate of subjects who showed HBsAg loss(24, 48 weeks after drug administration)
- The rate of subjects who showed HBsAg seroconversion(24, 48 weeks after drug administration)
- The rate of subjects who showed Virologic breakthrough(12, 24, 36, 48 weeks after drug administration)
研究者
研究点 (20)
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