A Multicenter, Randomized, Placebo Controlled, Double-blinded, Phase 4 Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- At 8 weeks, the change of ALT level compared to baseline
研究概览
简要总结
This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded.
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
- •Patients with Chronic liver disease(presented with abnormal serum ALT levels >6 months and twice continuously or abnormal area of liver through medical imaging test within 6 months
- •Abnormal serum ALT levels at screening and baseline
排除标准
- •Subjects who have diseases that liver cirrhosis, liver cancer, renal dysfunction etc.
- •Subjects who are taking medications or supplements related to chronic liver disease, fatigue.
研究组 & 干预措施
DWJ1464
UCDA 100 mg, TID
干预措施: DWJ1464 (Drug)
Placebo of DWJ1464
Placebo of DWJ1464, TID
干预措施: Placebo of DWJ1464 (Drug)
结局指标
主要结局
At 8 weeks, the change of ALT level compared to baseline
时间窗: 8 weeks after randomization
次要结局
- At 4, 8 weeks, the change of AST level compared to baseline(4, 8 weeks after randomization)
- At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline(4, 8 weeks after randomization)
- At 8 weeks, the change of liver function comparator Fibrotest compared to baseline(4, 8 weeks after randomization)
- At 4 weeks, the change of ALT level compared to baseline(4 weeks after randomization)
- At 8 weeks, the change of liver function comparator Fibroscan compared to baseline(4, 8 weeks after randomization)
- At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline(4, 8 weeks after randomization)