A Phase 2 interventional study of BAY3018250 and Placebo to BAY3018250 in Thrombolysis and Symptomatic Proximal Deep Vein Thrombosis, sponsored by Bayer. Completed at 68 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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' when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT.
BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors.
The main purposes of this study are to learn:
For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time.
And researchers will collect the number of bleeding events that require medical attention.
The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo.
Researchers will closely monitor participants for 90 days after receiving the study treatment.
During the study, the doctors and their study team will:
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following:
Exclusion Criteria:
Planned or current use of the following medications:
Participants will receive BAY3018250 Dose 1.
Drug: BAY3018250
Participants will receive BAY3018250 Dose 2.
Drug: BAY3018250
Participants will receive placebo to BAY3018250.
Drug: Placebo to BAY3018250
Dose 1 or dose 2 of BAY3018250
Matching placebo to BAY3018250
AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound
Area under the curve (AUC) with respect to the measurement time points at 6 hours, 24 hours, 7 days and 30 days of the ratio to baseline of clot burden
Time frame: at 6 hours, 24 hours, Day 7, Day 30
Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition)
The classify of bleeding events use the International Society on Thrombosis and Haemostasis (ISTH) definitions.
Time frame: up to Day 15
Ratio to baseline of clot burden, as assessed by quantitative ultrasound
Time frame: at 6 hours, 24 hours, Day 7, Day 30 and Day 90
Change from baseline in leg pain severity
Likert pain scale is used as a quantitative measure of patient reported pain based on the participant´s judgement. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Time frame: at 6 hours, 24 hours, Day 7, Day 30 and Day 90
Change from baseline in PVFS scale
PVFS stands for post venous thromboembolism functional status. PVFS scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), with higher scores being worse and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle.
Time frame: at Day 7, Day 30 and Day 90
Number of participants with recurrent venous thromboembolism
Time frame: up to Day 90
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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