In short
Currently, there is 1 ongoing clinical trial investigating thrombolysis treatment for patients with proximal deep vein thrombosis. This trial is being conducted across multiple European countries and is testing an investigational medication called BAY 3018250 in combination with low molecular weight heparin to assess its effectiveness and safety in breaking down blood clots in deep veins.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Slovakia
- Spain
Study on the Effectiveness and Safety of BAY 3018250 and Low Molecular Weight Heparin for Patients with Proximal Deep Vein Thrombosis
This clinical trial is investigating a new treatment option for people with proximal deep vein thrombosis (DVT), a condition where blood clots form in the deep veins, typically in the legs. The study focuses on testing an investigational medication called BAY 3018250, which is designed to help dissolve these blood clots.
Main inclusion criteria: The trial is open to men and women who are 18 years or older. Women must be postmenopausal (no longer having periods) or have had a hysterectomy. Participants must have an acute symptomatic proximal DVT confirmed by compression ultrasound, with symptoms lasting 14 days or less. The clot must be located in specific veins such as the popliteal vein (behind the knee), femoral vein (in the thigh), common femoral vein (upper thigh), or external iliac vein (in the pelvis). Patients must already be receiving treatment with blood thinners like low molecular weight heparins or direct oral anticoagulants. Body weight must be between 50 kg and 130 kg, and participants must provide informed consent.
Main exclusion criteria: The trial cannot accept patients who have a history of allergic reactions to the study medication, severe liver disease, or uncontrolled high blood pressure. Pregnant or breastfeeding women are excluded for safety reasons. Patients who have had a stroke in the past 6 months, have active bleeding or high bleeding risk, underwent major surgery in the past 30 days, or have cancer that is not in remission cannot participate. Those currently enrolled in another clinical trial are also excluded to avoid interference with study results.
Focus and goal: The primary goal of this study is to evaluate how well BAY 3018250 works at breaking down blood clots and to assess its safety profile. Participants will be randomly assigned to receive either the investigational medication or a placebo solution in a double-blind design, meaning neither patients nor researchers know which treatment is being given. The clot size will be measured using quantitative ultrasound at multiple time points: 6 hours, 24 hours, Day 7, and Day 30 after starting treatment. Safety will be monitored by tracking any bleeding events up to Day 15. Additional assessments will evaluate changes in leg pain severity and functional status at Day 7, Day 30, and Day 90, as well as monitoring for any recurrence of blood clots.
Investigational drug: BAY 3018250 is a thrombolytic agent, meaning it helps break down blood clots. It is administered as a concentrate for solution for infusion, given subcutaneously (injected under the skin). The medication works by enhancing the body's natural ability to dissolve clots, potentially through activating enzymes that break down fibrin, a key component of blood clots. This medication is still under investigation and not yet widely used in standard medical practice. The study is expected to conclude by October 2025.
Summary
Currently, there is one active clinical trial investigating thrombolysis for patients with proximal deep vein thrombosis. This trial is notable for its wide geographic reach, being conducted across 11 European countries including Germany, Bulgaria, Czechia, Slovakia, Belgium, Italy, Netherlands, France, Hungary, Greece, and Spain. The study represents an international effort to evaluate a new thrombolytic medication, BAY 3018250, which aims to actively dissolve blood clots rather than simply prevent their growth.
The trial employs a rigorous double-blind, placebo-controlled design and includes comprehensive monitoring of both effectiveness and safety. Participants will be followed for 90 days with regular ultrasound assessments to measure clot reduction and monitoring for potential complications. The broad inclusion criteria allow for participation of adults with confirmed proximal DVT who are already receiving standard blood-thinning therapy, while safety exclusions focus on protecting patients at higher risk for bleeding complications.
This research is significant as it explores whether thrombolytic therapy can provide better outcomes for DVT patients beyond standard anticoagulation treatment, potentially reducing long-term complications and improving recovery times. The expected completion date is October 2025.
