This clinical trial is focused on studying a condition known as proximal deep vein thrombosis (DVT), which is a type of blood clot that forms in the deep veins, usually in the legs. The study is investigating a treatment called BAY 3018250, which is a concentrate for solution for infusion. This means it is a liquid form of medication that is given through a needle into a vein. The trial will also involve a comparison with a placebo solution to help understand the effects of the treatment.
The purpose of the study is to learn more about how well BAY 3018250 works and how safe it is for people with proximal deep vein thrombosis. Participants in the study will receive either the treatment or a placebo, and their progress will be monitored over a period of time. The study will look at how the treatment affects the blood clot and any side effects that may occur. The trial will also involve the use of low molecular weight heparin, a type of medication that helps prevent blood clots, given by injection under the skin.
Throughout the study, participants will have regular check-ups to assess the size of the blood clot and any changes in symptoms, such as leg pain. These assessments will be done using ultrasound, a method that uses sound waves to create images of the inside of the body. The study will last for several months, with follow-up visits to monitor the participants’ health and the effectiveness of the treatment. The goal is to provide valuable information that could lead to better treatment options for people with proximal deep vein thrombosis.
1joining the study
Upon joining the study, the patient will be randomly assigned to receive either the BAY 3018250 solution or a placebo solution. This process is double-blind, meaning neither the patient nor the researchers know which solution is being administered.
2medication administration
The medication, BAY 3018250, is administered as a concentrate for solution for infusion. It is given subcutaneously, which means it is injected under the skin.
The frequency and dosage of the medication will be determined by the study protocol and will be explained to the patient by the medical team.
3monitoring and assessments
The patient’s clot burden will be assessed using quantitative ultrasound at several time points: 6 hours, 24 hours, Day 7, and Day 30. This helps to measure the effect of the medication on clot lysis.
The patient will also be monitored for any bleeding events up to Day 15, as these are important safety assessments.
4follow-up evaluations
Additional assessments will be conducted at Day 7, Day 30, and Day 90 to evaluate changes in leg pain severity and functional status after venous thromboembolism.
The patient will be checked for any recurrence of venous thromboembolism up to Day 90.
5completion of the study
The study is expected to conclude by October 3, 2025. The patient will be informed about the results and any further steps if necessary.
Who Can Join the Study?
Men and women who are either postmenopausal (no longer have menstrual periods) or have had a hysterectomy (surgery to remove the uterus) and are aged 18 years or older.
Have an acute symptomatic proximal deep vein thrombosis (DVT), which is a blood clot in a large vein, confirmed by a test called compression ultrasound (CUS). The following conditions must be met:
Symptoms have lasted 14 days or less.
The clot is in one of the following veins: the popliteal vein (behind the knee), the femoral vein (in the thigh), the common femoral vein (upper thigh), or the external iliac vein (in the pelvis).
The most upper part of the clot can be clearly seen.
Currently receiving treatment with blood thinners, specifically LMWHs (low molecular weight heparins) and/or DOACs (direct oral anticoagulants), as per the instructions for these medications.
Body weight is between 50 kg (about 110 pounds) and 130 kg (about 286 pounds).
Have signed a document called an informed consent, which means they understand the study and agree to participate.
Who Cannot Join the Study?
Patients who have a history of allergic reactions to the study medication. An allergic reaction is when your body reacts badly to something, causing symptoms like rash, itching, or trouble breathing.
Patients with severe liver disease. This means the liver, which helps clean your blood and digest food, is not working well.
Patients with uncontrolled high blood pressure. This is when your blood pressure is too high and not managed by medication or lifestyle changes.
Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Patients who have had a stroke in the past 6 months. A stroke is when blood flow to a part of the brain is stopped, causing brain cells to die.
Patients with active bleeding or a high risk of bleeding. This means there is ongoing bleeding or a high chance of bleeding happening.
Patients who have had major surgery in the past 30 days. Major surgery is a big operation that usually requires a hospital stay.
Patients with cancer that is not in remission. Remission means the cancer is not active or growing.
Patients who are currently participating in another clinical trial. This is to avoid any interference with the study results.
BAY 3018250 is a medication being studied for its ability to help dissolve blood clots in patients with deep vein thrombosis (DVT), which is a condition where blood clots form in the deep veins, usually in the legs. The trial aims to determine how effective this medication is at breaking down these clots and to evaluate its safety for patients experiencing this condition.
Proximal Deep Vein Thrombosis – Proximal deep vein thrombosis (DVT) is a condition where a blood clot forms in the deep veins, typically in the legs, often in the thigh or pelvis. This clot can cause swelling, pain, and redness in the affected area. The condition progresses as the clot may grow larger, potentially leading to complications if it dislodges and travels to the lungs, causing a pulmonary embolism. Over time, the clot can cause damage to the vein, leading to long-term symptoms such as swelling and discomfort. The body’s natural processes may gradually break down the clot, but this can take weeks or months. Monitoring and managing symptoms are crucial to prevent further complications.
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