International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 757
- 试验地点
- 7
- 主要终点
- Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters
研究概览
简要总结
The three purposes of this study are the following:
- To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
- To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
- To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.
详细描述
The study consists in a 6-month treatment period followed by an observational period of 3 to 6 months with a month 9 visit and a phone/contact visit at month 12.
All participants who complete the 6-month treatment period are re-randomized to either the idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect sub-study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed acute symptomatic DVT of the lower limbs
排除标准
- •Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension)
- •Active bleeding or high risk for bleeding.
- •Pregnancy or childbearing potential without proper contraceptive measures.
- •Breastfeeding
- •Known allergy to idraparinux, SSR126517E, or egg proteins
- •Indication of prolonged anticoagulation for other reason than DVT of the lower limbs
- •Symptomatic pulmonary embolism (PE)
- •Life expectancy < 6 months.
研究组 & 干预措施
Idrabiotaparinux
Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months.
In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration)
干预措施: Idrabiotaparinux sodium (Drug)
Idrabiotaparinux
Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months.
In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration)
干预措施: Avidin (Drug)
Idrabiotaparinux
Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months.
In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration)
干预措施: Placebo (for Avidin) (Drug)
Idraparinux
Idraparinux sodium, 2.5 mg, once-weekly for 6 months
In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration)
干预措施: Idraparinux sodium (Drug)
Idraparinux
Idraparinux sodium, 2.5 mg, once-weekly for 6 months
In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration)
干预措施: Placebo (for Avidin) (Drug)
结局指标
主要结局
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters
时间窗: Day 183
Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion
时间窗: Day 183 to Day 188
次要结局
- Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations(Days 15, 36, 57, 92 and 183)
- Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC)(First 6 months)
- Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC(First 6 months)