The Multi Center, Randomized, Double-blind, Positive Controlled Phase II Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 17
- 主要终点
- The decline range of serum ALT after 4 weeks of treatment
研究概览
简要总结
The study adopted the superiority design of multi center, randomized, double-blind, positive control drug, dose finding, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group, high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
详细描述
Explore the safety and efficacy of different doses of bicyclol in treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug.
The study adopted the design of multi center, randomized, double-blind, dose finding, positive control drug, superiority test, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group and high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
low dose group
Patients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks.
干预措施: bicyclol tablet 25mg (Drug)
high dose group
Patients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks.
干预措施: bicyclol tablet 50mg (Drug)
positive drug control group
Patients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks.
干预措施: polyene phosphatidylcholine capsule 456mg (Drug)
结局指标
主要结局
The decline range of serum ALT after 4 weeks of treatment
时间窗: after 4 weeks of treatment
The decrease value of serum ALT after 4 weeks of treatment compared to the baseline
次要结局
- The decrease value of serum AST compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks(after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks)
- The decrease value of serum ALT compared to the baseline of treatment for 1, 2, 6, 8 weeks and follow-up for 2, 4 weeks(after 1, 2, 6, 8 weeks treatment and follow-up for 2, 4 weeks)
- The decrease rate of serum ALT compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks(after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks)
- The time from treatment to ALT normalization(treatment period)
- The ratio of subjects whose ALT and AST declined more than 50% compared to the base line of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks(after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks)
- The serum ALT and AST normalization rate of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks(after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks)
- The area under curve of ALT and AST of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks(after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks)