2023-503315-15-00招募中2 期
(22138) A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of BAY 3018250 in patients with symptomatic proximal deep vein thrombosis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 443
- 试验地点
- 82
- 主要终点
- Area under the curve AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7 and Day 30
研究概览
简要总结
The primary objectives are to quantify the effect of BAY 3018250 on clot lysis in patients with proximal DVT, and to assess the safety of BAY 3018250 in patients with proximal DVT.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall study
- 盲法
- Double (Monitor, Subject, Carer, Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female (if postmenopausal or hysterectomized) aged 18 years or older
- •Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following: a. duration of symptoms 14 days or less b. Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein c. adequate visualization of the most proximal end of the thrombus d. receiving therapeutic dose anticoagulation with LMWHs and/or DOACs according to the respective product labels
- •Measured body weight within 50 to 130 kg
- •Signed informed consent
排除标准
- •Acute symptomatic PE requiring systemic or catheter-directed thrombolytic therapy, catheter-directed mechanical thrombectomy, or surgical embolectomy
- •Active bleeding or high risk for bleeding (at the discretion of the investigator)
- •Recent (<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage, or major surgery or severe trauma (at the discretion of the investigator)
- •Active cancer, i.e., locally active, regionally invasive or metastatic and/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma
- •Therapeutic-dose anticoagulants for > 72 hours before randomization, or current use of vitamin K antagonists
- •Planned or current use of the following medications: Planned or current use of the following medications: a. Any antiplatelet therapy, except ASA ≤100 mg/day, b. Antifibrinolytic drugs, c.Therapeutic antibodies
- •Male participants with WOCBP partners unwilling to use highly effective contraception from start of study intervention until end of study.
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Area under the curve AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7 and Day 30
Area under the curve AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7 and Day 30
Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition) up to Day 15
Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition) up to Day 15
次要结局
- Ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7, Day 30 and Day 90, respectively.
- Change from baseline in leg pain severity at 6h, 24h, Day 7, Day 30 and Day 90 (Likert pain scale)
- Change from baseline in post- venous thromboembolism functional status (PVFS) scale at Day 7, Day 30 and Day 90
- Number participants with recurrent venous thromboembolism (VTE) up to Day 90
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (82)
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