A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis

Launched by BAYER · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BAY3018250 to see how well it works and how safe it is for people with a condition known as proximal deep vein thrombosis (DVT). DVT occurs when a blood clot forms in the deep veins of the leg, particularly near the hip, thigh, or knee, and can lead to serious complications if the clot travels to the lungs. The usual treatment involves blood thinners, but they may not work for everyone or dissolve the clot quickly. In this trial, researchers will compare BAY3018250 to a placebo (a treatment that looks like the drug but has no active ingredients) to determine its effectiveness in dissolving blood clots.

To be eligible for this trial, participants must be 18 years or older and have symptoms of proximal DVT for 14 days or less, confirmed by an ultrasound test. They should also be receiving certain types of blood thinners. Participants will be randomly assigned to receive either a high or low dose of BAY3018250 or the placebo. Throughout the study, which lasts about 90 days, participants will have regular check-ups, including blood tests and ultrasound scans to monitor their condition. The goal is to gather information about how well BAY3018250 works and to ensure it is safe for those with this condition.

Gender

ALL

Eligibility criteria

• Inclusion 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:
• • 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 Criteria:
• • 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.