JPRN-jRCT2031230269招募中3 期
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
Saiki Yoshikatsu0 个研究点目标入组 70 人开始时间: 2023年7月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1.18 years old or older and 85 years or younger at the time when informed consent is obtained
- •2.Receiving elective cardiovascular surgery using a cardiopulmonary bypass
- •3.Platelet count of 178,000 / microliter or more at laboratory tests at screening
- •4.Fibrinogen count of 264 mg/dL or more at laboratory tests at screening
- •5.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
- •1.Having been administered a specified prohibited concomitant drug or prohibited concomitant therapy before administration of the study drug
- •2.Having congenital antithrombin III deficiency
- •3.Having a history of heparin-induced thrombocytopenia
- •4.Having a history of antiphospholipid syndrome
- •5.Receiving surgery other than cardiovascular surgery at the same time
- •6.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
- •7.Having congenital or acquired coagulation factor deficiency or abnormality
研究者
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