NCT02744833终止1 期
A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of GMI-1271 in patients with calf-level DVT by assessment with vital signs, standard laboratory blood tests, electrocardiogram, and adverse event evaluation.
研究概览
简要总结
This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Male or female
- •Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)
- •Willing and able to participate in all required evaluations and procedures in this study protocol
排除标准
- •History or presence of clinically significant medical condition or disease in the opinion of the principal investigator
- •Uncontrolled acute life-threatening bacterial, viral or fungal infection
- •Unable to be treated with systemic anticoagulants
- •Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics
- •Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years
- •Current or recent cancer treatment
- •Major surgery within 21 days or planned surgery during the study period
- •Female subjects who are pregnant or breastfeeding
- •Known history of HIV, Hepatitis B or Hepatitis C
- •Alcoholism or drug use
- •Clinically significant cardiovascular disease
研究组 & 干预措施
GMI-1271
Experimental
干预措施: GMI-1271 (Drug)
Enoxaparin Sodium (Lovenox®)
Active Comparator
干预措施: Enoxaparin Sodium (Lovenox®) (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of GMI-1271 in patients with calf-level DVT by assessment with vital signs, standard laboratory blood tests, electrocardiogram, and adverse event evaluation.
时间窗: 19 days
Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).
次要结局
- To evaluate the effects of GMI-1271 on the incidence of bleeding time(19 days)
- To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)(19 days)
- To evaluate the effects of GMI-1271 on biomarkers of coagulation(19 days)
- To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound(19 days)
研究者
研究点 (1)
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