Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active- Controlled Open Label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 35
- 主要终点
- The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a single administration of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.
详细描述
Currently available anticoagulant therapies for the prevention of VTE include low molecular weight heparins, pentasaccharides and vitamin K antagonists, all of which have inherent limitations(1-3).
Improved anticoagulant agents are therefore required(4). A novel antithrombotic agent requires demonstration of both efficacy and safety in relevant populations. Phase II studies are frequently performed in patients undergoing total hip replacement and/or total knee replacement because of the high and well documented incidence of deep vein thrombosis in the absence of adequate thromboprophylaxis(5-7).
In this study, we assess the safety and efficacy of TB-402, a novel antithrombotic agent that partially inhibits factor VIII, in the prevention of VTE in patients undergoing total knee 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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged > 18 and < 80 years old
- •Female patients should be post menopausal
- •Patients undergoing primary elective total knee replacement surgery
- •Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
排除标准
- •Body weight < 50 kg or > 100 kg
- •Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee
- •Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year
- •Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study
- •Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg)
- •History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year
研究组 & 干预措施
3
1.2 mg/kg TB-402
干预措施: TB-402 (Drug)
1
0.3 mg/kg TB-402
干预措施: TB-402 (Drug)
2
0.6 mg/kg TB-402
干预措施: TB-402 (Drug)
4
干预措施: Enoxaparin (Drug)
结局指标
主要结局
The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study.
时间窗: All visists from randomization to end of study
Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE.
时间窗: Prior to hospital discharge Day 7-11
次要结局
- Incidence of major bleeding events(All visists from randomization to end of study)
- Incidence of clinically significant non-major bleeding events(All visits from randomization to end of study)
- Incidence of minor bleeding events(All visits from randomization to end of study)
- Incidence of all cause mortality(All visits from randomization to end of study)
- Incidence of adverse events(All visists from randomization to end of study)