NCT03270735Unknown4 期
A Multi-centre, Randomised, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Snake Venom Thrombin Injection in the Treatment of Moderate to Severe Hemoptysis
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年6月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- AEs and SAEs
研究概览
简要总结
This is a multi-centre, randomised, double blind, placebo controlled clinical study which is designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to severe hemoptysis.
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
- •18-75 years;
- •Hemoptysis >=100 mL within 24 hours;
- •Bronchiectasis diagnosed by chest high resolution CT;
- •Patient, family or guardian is willing to sign the informed consent form.
排除标准
- •With severe hepatic or renal insufficiency, ALT>3 ULN, creatinine clearance <30 mL/min or serum creatinine ≥200 µmol/L or ≥2.5 mg/dL;
- •Uncontrollable hypertension (SBP>180mmHg or DBP>110mmHg) or hypotension shock (SBP<90 mmHg) at randomization;
- •History of thrombosis, patients who have undergone thrombosis, or who have severe hematologic diseases;
- •Patient with bleeding caused by DIC or vascular disease;
- •Patient with coagulation dysfunction
- •Patient with abnormal coagulation function or other bleeding disease (including clinical congenital bleeding disorders, such as von Willebrand disease or acquired hemophilia; hemorrhagic disease; and significant unexplained hemorrhagic disease)
- •Platelet count <100×109 /L;
- •known allergic to aspirin, clopidogrel, heparin, snake venom blood clotting enzyme, or any component in the study drug allergy or allergic constitution;
- •Women who are pregnant or lactating and women of child-bearing agewho do not take reliable contraceptive measures;
- •Patients who are or are planning to participate in other clinical trials during the study period;
- •Within 72 hours before using the following products including Hemocoagulase For Injection (邦亭®), injection spearhead haemocoagulase (巴曲亭®), Haemocoagulase Agkistrodon for Injection (苏灵®), Hemocoagulase Atrox for Injection (立止血®), leaf pigment or other hemostatic agents;
- •Life expectancy of less than 3 months;
- •Any other patients who have been judged unfit to participate in this clinical study, including those who are unable or unwilling to comply with the protocol requirements;
- •Patients who had participated in other clinical studies within three months prior to the study.
研究组 & 干预措施
Treatment
Experimental
Snake venom thrombin
干预措施: Snake venom thrombin (Treatment) (Drug)
Placebo
Placebo Comparator
Snake venom thrombin simulant
干预措施: Placebo (Drug)
结局指标
主要结局
AEs and SAEs
时间窗: 7 days
The incidence of AEs and SAEs
次要结局
- Effective rate of treating hemoptysis(72 hours)
研究者
研究点 (1)
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