NCT05205863已完成1 期
A Phase 1/2 Study of the Dose-Response in Pharmacodynamics and Safety of Prothrombin Complex Concentrate Cofact in Healthy Subjects Under Vitamin K Antagonist Anticoagulation.
Prothya Biosolutions1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年11月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Peak thrombin generation at 30 minutes after end of the Cofact infusion
研究概览
简要总结
This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of nonchildbearing potential.
- •Healthy subjects.
排除标准
- •Evidence of coagulation disturbances, or disposition for thrombo-embolic events
- •Liver function tests more than 1.2 times the upper normal limits
- •Participants with thyroid disorders as evidenced by assessment of TSH levels outside the normal reference range at screening.
- •Prior history of thromboembolic complications including those in first degree relatives.
- •Glomerular filtration rate (GFR) is lower than estimated GFR 62 mL/min/1.73 m2 using the Modification of Diet in Renal Disease Study equation.
- •Anaphylactic or systemic reactions to human plasma, plasma products, or blood products.
- •History of hypersensitivity to active or inactive excipients of VKA
- •Gastrointestinal disease that may impair VKA absorption..
- •Participation in another clinical study <30 days prior to study entry.
- •Any clinically significant history of or current clinically significant disease or disorder as judged by the Investigator.
- •Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -11 or Day -
- •Positive pregnancy test at screening, Day -11, or Day -1.
结局指标
主要结局
Peak thrombin generation at 30 minutes after end of the Cofact infusion
时间窗: 30 minutes post Cofact infusion
次要结局
- Safety outcome(up to Day 15)
- Changes in ETP(24 hours post Cofact infusion)
- Coagulation markers(up to Day 15)
- Concentration in clotting factors(up to Day 15)
- Coagulation activation markers(up to Day 15)
研究者
研究点 (1)
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