NCT01561937已完成1 期
Use of Recombinant FVIIa to Mitigate Warfarin Anticoagulation Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Bleeding duration measured in minutes after biopsy B1 in trial part B
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •INR below or equal to 1.2
排除标准
- •The receipt of any investigational drug within 1 month prior to this trial
- •Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drug) within 14 days prior to trial
- •African-American race
- •Weight above 160 kg
- •Supplemental Vitamin K use
研究组 & 干预措施
Pre-warfarin treatment (trial part A)
Experimental
干预措施: warfarin (Drug)
Post-warfarin treatment (trial part B)
Experimental
干预措施: eptacog alfa (activated) (Drug)
Post-warfarin treatment (trial part B)
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Bleeding duration measured in minutes after biopsy B1 in trial part B
时间窗: From onset of bleeding till the end of the bleeding
Bleeding duration measured in minutes after biopsies in trial part A
时间窗: From onset of bleeding till the end of the bleeding
次要结局
- Adverse events, including thrombotic events(From day 0 to days 14-28)
- Blood volume reported in millilitres after biopsies in trial part A(From onset of bleeding till the end of the bleeding)
- Change in coagulation-related parameters after biopsy B1(From baseline to 3 hours after B1)
- Change in coagulation-related parameters after biopsy B2(From baseline to 3 hours after B2)
- Blood volume reported in millilitres after biopsy B1 in trial part B(From onset of bleeding till the end of the bleeding)
- Clot dynamics: K in minutes (trial part B)(Time to achieve 20mm clot strength)
- Clot dynamics: R in minutes (trial part B)(Time to onset of clot formation)
- Change in coagulation-related parameters after biopsy B3(From baseline to 3 hours after B3)
研究者
研究点 (1)
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