Status:
COMPLETED
A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis
Lead Sponsor:
Bayer
Conditions:
Thrombolysis
Symptomatic Proximal Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT). DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called 'proximal...
Eligibility Criteria
Inclusion
- 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:
- duration of symptoms 14 days or less
- 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
- adequate visualization of the most proximal end of the thrombus
- receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respective product labels
- Measured body weight within 50 to 130 kg
- Signed informed consent
Exclusion
- Acute symptomatic pulmonary embolism (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:
- Any antiplatelet therapy, except acetylsalicylic acid (ASA) ≤100 mg/day
- Antifibrinolytic drugs
- Therapeutic antibodies
- Male participants with women of childbearing potential (WOCBP) partners unwilling to use highly effective contraception from start of study intervention until end of study.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2025
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT06149520
Start Date
January 15 2024
End Date
December 2 2025
Last Update
January 7 2026
Active Locations (68)
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1
Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
Antwerp, Belgium, 2650
2
Imelda - Vascular Surgery Dept
Bonheiden, Belgium, 2820
3
Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department
Genk, Belgium, 3600
4
UZ Gent
Ghent, Belgium, 9000