Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 4
- 主要终点
- bacillary sputum smear clearance
研究概览
简要总结
The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.
详细描述
Main end-point is negative sputum conversion rate after one month in patients on V7 vs placebo arm, both arms will receive conventional anti-tuberculosis chemotherapy consisting of 1st and/or 2nd line TB drugs according to baseline diagnosis
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of TB
- •sputum smear positive
排除标准
- •likely to be non-compliant due to drug and/or alcohol abuse
- •mentally unfit to comply with treatment
研究组 & 干预措施
V7: Heat-inactivated M. vaccae pill
Daily pill of V7 together with standard tuberculosis therapy
干预措施: V7 (Biological)
Placebo pill
one pill of placebo pill once per day together with standard of care TB drugs
干预措施: Placebo (Biological)
结局指标
主要结局
bacillary sputum smear clearance
时间窗: two years
blinded assessment of sputum clearance score
次要结局
- changes in inflammation markers(2 years)
- changes in body weight(2 years)
- changes in body mass index (BMI)(2 years)
- changes in liver function test(2 years)