NCT01344954已完成2 期
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 36
- 主要终点
- Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 18 years.
- •Written informed consent.
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
排除标准
- •Pregnancy at the time of screening.
- •Indication for anticoagulation other than post-operative thromboprophylaxis.
- •Active bleeding or high risk of bleeding.
- •Anticipated continued use of neuraxial catheter after surgery.
- •Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
- •Uncontrolled hypertension.
- •Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
- •Creatinine clearance <30 mL/min.
- •Antiplatelet agents other than low dose aspirin (< 200mg).
- •The use of intermittent pneumatic compression.
- •Known hypersensitivity to contrast media or rivaroxaban.
- •Known drug or alcohol abuse.
- •Active malignant disease or current cytostatic treatment.
- •Stroke within the previous month.
- •Participation in an investigational drug study within the past 30 days or previous participation in this study.
- •Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.
研究组 & 干预措施
25mg TB-402
Experimental
干预措施: TB-402 (Drug)
50mg TB-402
Experimental
干预措施: TB-402 (Drug)
10mg QD Rivaroxaban
Active Comparator
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE
时间窗: Randomisation to post-operative day 35
次要结局
- Incidents of total DVT(Randomisation to Post-Operative day 35)
- Incidents of VTE-related death(Randomisation to Post-Operative day 35)
- Incidents of major VTE(Randomisation to Post-Operative day 35)
- Incidents of proximal/distal DVT(Randomisation to Post-Operative day 35)
- Incidents of pulmonary embolism(Randomisation to Post-Operative day 35)
- Incidents of Major VTE(Randomisation to Post-Operative day 70)
研究者
研究点 (36)
Loading locations...
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