NCT04803955招募中2 期
Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients: a Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Trial
Tianjin Chasesun Pharmaceutical Co., LTD1 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2021年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Delta SOFA (ΔSOFA)
研究概览
简要总结
Phase II study of Kukoamine B Mesilate in Sepsis Patients
详细描述
To Assess Efficacy,Safety,Pharmacokinetics of Kukoamine B Mesilate in Sepsis Patients
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) The age of ≥ 18 years of age and ≤ 85 years of age, gender is not limited;
- •(2) Meeting the diagnostic criteria for sepsis 3.0, i.e. sequential organ failure score (SOFA) increased by ≥2 points from baseline for patients with confirmed or suspected infection;
- •(3) Confirmed or suspected bacterial infection (Pulmonary, abdominal，urinary system or hematogenous infections);
- •(4) Infection-related organ failure does not exceed 48 hours; organ failure is defined as circulation, (SOFA) ≥ 3 points in at least one organ or system of the respiratory, kidney, liver, coagulation and central nervous system;
- •(5) Childbearing age within six months without child care plan and agreed to take effective measures during the study of contraception;
- •(6) Patients or guardians signed informed consent.
排除标准
- •(1) Pregnancy or lactation women；
- •(2) Patients are expected to live less than 48 hours;
- •(3) Patients had poor control of malignant tumor, end-stage lung disease and other end-stage diseases, or had acardiac arrest，acute pulmonary embolism，blood transfusion response and acute coronary syndrome within 4 weeks prior to enrollment;
- •(4) The patient has the following chronic organ dysfunction or immunosuppression (based on the chronic health scoring assessment of the APACHE II score) : 1) heart: New York heart association cardiac function IV; 2) breathing: chronic obstructive, obstructive, or vascular lung disease can lead to severe restrictions on activities, i.e. the inability to go upstairs or to do housework; Or clear chronic hypoxia, CO2 retention, secondary real erythrocyte, severe pulmonary hypertension (mPAP> 40 mmHg) or respiratory muscle dependence; 3) kidneys: receiving long-term dialysis; 4) liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; The upper digestive tract hemorrhage caused by portal hypertension; Or previous liver failure/hepatic encephalopathy/hepatic coma; 5) of immune function: accept the treatment of impact resistance to infection, such as immune suppression therapy, chemotherapy, radiotherapy or chemotherapy within 6 months, long-term (continuous use ≥3 weeks) use of glucocorticoids or recent (within 5 days before screening) cumulative use of prednisone or equivalent dose ≥100mg , or sickness impact resistance to infection, such as leukemia, lymphoma and AIDS);
- •(5) Previous solid organ or bone marrow transplantation;
- •(6) Plant survival status;
- •(7) Confirmed or highly suspected of acute infectious diseases such as viral hepatitis activity , or clinically confirmed active tuberculosis;
- •(8) Patients with sinus bradycardia (less than 60 per minute);
- •(9) Uncontrolled bleeding in the past 24 hours（Clinical judgment requires transfusion support）;
- •(10) Large area burns or chemical burns (III degree burns area > 30% BSA);
- •(11) The average arterial pressure was < 65 mmHg after adequate liquid resuscitation and vasoactive drug therapy;
- •(12) Acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (ANC < 500 / mm3);
- •(13) Allergic to the active ingredient or its auxiliary materials;
- •(14) The medication patients are using may severely affect the metabolism of the drug;
- •(15) Patients and (or) guardians have signed a Do Not Rescue (DNR), or decided to withdraw life support (withdraw) or restrict life support for the intensity (withhold) and sign the informed consent form;
- •(16) Participated in clinical intervention test in 3 months;
- •(17) The subject is a researcher or his immediate family member, or may have improper informed consent;
- •(18) The investigator considers it inappropriate for the patient to participate in this test.
研究组 & 干预措施
16mg,KB
Experimental
Group A:16mg,Q8h±3min,Day1-Day7
干预措施: 16mg，KB (Drug)
Placebos
Placebo Comparator
Group B:Placebos,Q8h±3min,Day1-Day7
干预措施: Placebos (Drug)
结局指标
主要结局
Delta SOFA (ΔSOFA)
时间窗: Day 8 after the first dose (Within 24 hours after the last dose on day 7)
Change in SOFA scale from baseline.
次要结局
- Proportion of patients transferred out of ICU(7 days after the first dose)
- Clinical Outcome Composite Endpoint(28 days after the first dose)
- Quantification of IL-6(Day 2, 4 , 8 after the first dose (Within 24 hours after the last dose on day 7))
- Delta SOFA (ΔSOFA)(Day 1, 3, 5 after the first dose)
- Duration of ICU stay and absence(28 days after the first dose)
- Rate of adverse events/serious adverse events(From date of singing informed consent until the 29 days after the first dose)
- Proportion of patients with 7-day all-cause deaths(7 days after the first dose)
- Duration of use and abstention of life support treatment(28 days after the first dose)
研究者
研究点 (1)
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