NCT05957380已完成4 期
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
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
- 120
- 试验地点
- 1
- 主要终点
- HBV DNA(log10 IU/mL) change
研究概览
简要总结
This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects of ages in the range over 19
- •The subjects HBsAg positive for at least 6 months or has history of Chronic Hepatitis B
- •The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000 IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B
- •The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent
排除标准
- •The subjects who have been infected with HCV, HDV, HIV
- •The subjects who have Hemochromatosis, Wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency
- •The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma
研究组 & 干预措施
Treatment group
Experimental
干预措施: DA-2803 (Drug)
Treatment group
Experimental
干预措施: Placebo of DA-2803-R (Drug)
Reference group
Experimental
干预措施: DA-2803-R (Drug)
Reference group
Experimental
干预措施: Placebo of DA-2803 (Drug)
结局指标
主要结局
HBV DNA(log10 IU/mL) change
时间窗: 48 weeks
HBV DNA(log10 IU/mL) change compared to baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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