A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial to Evaluate the EBA, Safety and PK of Orally Administered LCB01-0371 in Adult Patients With Smear-positive Pulmonary Tuberculosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- EBA0-14
研究概览
简要总结
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
详细描述
This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.
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
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
- •The age of consent at the time of writing, only men and women under 75 years old over 19 years old
- •The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients
排除标准
- •Known history of Rifampicin or Isoniazid resistance
- •Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
- •Known History of nontuberculous mycobacteria positive
- •Other pulmonary disease which is impossible to participate in clinical trial except TB
研究组 & 干预措施
Group 1
LCB01-0371 800mg, QD
干预措施: LCB01-0371 800mg, QD (Drug)
Group 2
LCB01-0371 400mg, BID
干预措施: LCB01-0371 400mg, BID (Drug)
Group 3
LCB01-0371 800mg, BID
干预措施: LCB01-0371 800mg, BID (Drug)
Group 4
Tubes 3~5Tablet, QD
干预措施: Tubes 3~5Tablet, QD (Drug)
Group 5
Zyvox 600mg, BID
干预措施: Zyvox 600mg, BID (Drug)
Group 6
LCB01-0371 1200mg, QD
干预措施: LCB01-0371 1200mg, QD (Drug)
结局指标
主要结局
EBA0-14
时间窗: V2(Baseline, Day 1), V9(Day 15)
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15
次要结局
- EBA2-14(V4(Day 3), V9(Day 15))
- EBA2-7(V4(Day 3), V6(Day 8))
- EBA0-2(V2(Baseline, Day 1), V4(Day 3))