Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ta 1 improving immune function of monocyte for sepsis, used by flow cytometric to measure phagocytosis(CD11b, CD64), antigen presenting(HLA-DR, CD86 and PD-L1), and apoptosis(active caspase 3) on monocyte,
研究概览
简要总结
The purpose of this study is to determine whether thymosin alpha 1 is effective on improving monocyte function and has the desired pharmacologic activity for sepsis
详细描述
Part 1: To observe the function of thymosin alpha 1 in sepsis patients via improving phagocytosis, bacteria eradication and antigen-presenting on monocyte Part 2: Pharmacokinetics of thymosin alpha 1 for sepsis
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from the patients or their next of kin for patients unable to consent
- •Age ≥18 yrs
- •Presence of sepsis/ septic shock according to sepsis 3.0
排除标准
- •Pregnant or lactation period.
- •Age <18 yrs
- •Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month.
- •History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation;
- •Acute pancreatitis with no established source of infection.
- •Not expected to survive 28 days because of end-stage diseases.
- •Participation in another clinical trial.
研究组 & 干预措施
thymosin alpha 1
Subcutaneous injections of 1.6 mg thymosin alpha 1 twice per day for seven days, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
干预措施: thymosin alpha 1 (Drug)
Placebo
Subcutaneous injections of placebo (saline) twice per day for seven days
干预措施: Placebo (Other)
结局指标
主要结局
Ta 1 improving immune function of monocyte for sepsis, used by flow cytometric to measure phagocytosis(CD11b, CD64), antigen presenting(HLA-DR, CD86 and PD-L1), and apoptosis(active caspase 3) on monocyte,
时间窗: 28days
Phagocytosis was measured by expression of monocyte surface antigen CD64 and CD11b, as well as pHrodo™ BioParticles® Phagocytosis Kits to assessing phagocytic activity on monocyte; antigen presenting was measured by HLA-DR, costimulatory molecule CD86 and inhibitory molecule PD-L1 on monocyte; apoptosis was measured by active caspase 3 on monocyte
次要结局
- Relationship between concentration of Ta 1 and prognosis of sepsis patients, measured by concentration of Ta 1, 28-day all-cause mortality, 28-day clearance rate of pathogenic microorganism, ICU stays and hospital stays(28 days)
- Maximum observed serum concentration (Cmax) of Ta 1(7 days)
- Terminal serum half-life (T-HALF) of Ta 1(7 days)
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1(7 days)
- Time of maximum observed serum concentration (Tmax) of Ta 1(7 days)
研究者
Wu Jianfeng
Clinical Professor
Sun Yat-sen University