NCT01913431已完成4 期
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Group Study to Demonstrate the Comparison and Evaluation of Baracle Tab.® and Baraclude Tab.® for HBeAG Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)
研究概览
简要总结
This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.
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
- Triple (Participant, Care Provider, 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
- •Subjects with HbeAg Chronic Hepatitis B for at least six months starting from the Screening visit
- •Subjects with HBsAg-Positive diagnosed at the screening visit
- •Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit
- •For those who were diagnosed HBeAg-Positive, HBV DNA level should be equal or more than 1x10^5 copies/ml
- •For those who were diagnosed HBeAg-Negative, HBV DNA level should be equal or more than 1x10^5 copies/ml
- •Subjects who were NOT administrated any anti-viral agents including interferon or pegylated interferon
排除标准
- •Subjects with HCV, HDV or HIV
- •Subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
- •With medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
- •Less than 50ml/min of creatinine clearance diagnosed at the screening visit
- •More than 50 ng/ml of alpha-fetoprotein at the screening visit
- •Involved in other studies
研究组 & 干预措施
Baracle Tab.®
Experimental
(It can be also placebo) dosage: 2 tablets daily for 48 weeks
干预措施: Baracle Tab.® (Drug)
Baraclude Tab.®
Experimental
(It can be also placebo) dosage: 2 tablets daily for 48 weeks
干预措施: Baraclude Tab.® (Drug)
结局指标
主要结局
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)
时间窗: 52 weeks
measured at 24th week of the administration
次要结局
- the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)(52 weeks)
- the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)(52 weeks)
- the percentage of participants who have lost HBeAg(52 weeks)
研究者
研究点 (1)
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