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A study to learn more about how well BAY 3018250 works and how safe it is for people with proximal deep vein thrombosis
EU CTIS ID: 2023-503315-15-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.