jRCT2031230269进行中（未招募）不适用
A multicenter, single-arm, open-label, phase III clinical study to investigate the efficacy and safety of GB-0706 in patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 主要终点
- ACT 480 seconds or over
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 85age old under（—）
- 性别
- All
入选标准
- •18 years old or older and 85 years or younger at the time when informed consent is obtained
- •Receiving elective cardiovascular surgery using a cardiopulmonary bypass
- •Platelet count of 178,000 / microliter or more at laboratory tests at screening
- •Fibrinogen count of 264 mg/dL or more at laboratory tests at screening
- •Meeting all the inclusion criteria 1 to 4 and found to have Heparin Resistance according to the definition of Heparin Resistance specified in this study
排除标准
- •Having been administered a specified prohibited concomitant drug or prohibited concomitant therapy before administration of the study drug
- •Having congenital antithrombin III deficiency
- •Having a history of heparin-induced thrombocytopenia
- •Having a history of antiphospholipid syndrome
- •Receiving surgery other than cardiovascular surgery at the same time
- •Found to have a history of coagulation disorder (such as von Willebrand disease) for reasons such as a medical history of hemorrhagic disease or test history
- •Having congenital or acquired coagulation factor deficiency or abnormality
结局指标
主要结局
ACT 480 seconds or over
The percentage of subjects with ACT 480 seconds or over (improved Heparin resistance) after administration of the study drug (study drug dose (1), or, if the study drug is administered twice, study drug dose (2))
次要结局
- The change in ACT from the additional dose of heparin to after administration of the study drug(after administration of the study drug)
研究者
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