BAY 3389934 for Blood Clotting Disorder in Sepsis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks a safer and more effective treatment for individuals with sepsis-induced coagulopathy, a condition where severe infections cause uncontrollable blood clotting, damaging blood vessels and organs. Researchers are testing a new drug, BAY 3389934, to assess its safety and determine the appropriate dose for treatment. Participants will stay in an ICU, receiving either a low or higher dose of BAY 3389934, while doctors monitor for side effects. The trial targets individuals currently treated for sepsis-related clotting issues in a hospital ICU. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that BAY 3389934 is likely to be safe for humans?
Research has shown that BAY 3389934 is being tested for its safety in treating sepsis-induced coagulopathy, a blood clotting problem during severe infections. This treatment aims to manage blood clots that can seriously harm organs.
In earlier studies, the treatment was generally well-tolerated. As a "soft drug," it breaks down quickly in the body, potentially reducing side effects. Reports suggest it positively affects blood clotting and may help protect organs from damage.
However, since this is an early-stage study, researchers are closely monitoring for any adverse events, which are medical problems that might occur during the study. These events are carefully tracked to understand the treatment's safety at different doses.
The safety of BAY 3389934 remains under evaluation. This current study will provide more information on how well participants with sepsis-induced coagulopathy tolerate it.12345Why do researchers think this study treatment might be promising?
Most treatments for blood clotting disorders in sepsis rely on anticoagulants to prevent further clot formation. However, BAY 3389934 is unique because it offers a targeted approach, potentially altering the body's response to clotting without the broad anticoagulant effects. Researchers are excited about BAY 3389934 because it is administered as a continuous infusion, allowing for precise control over dosing, which could lead to more effective management of clotting with potentially fewer side effects. This new mechanism of action and delivery method could represent a significant advancement over current treatment options.
What evidence suggests that BAY 3389934 might be an effective treatment for sepsis-induced coagulopathy?
Research has shown that BAY 3389934 could be a promising treatment for blood clotting problems caused by sepsis. It blocks certain substances in the blood that cause clots to form. Studies indicate that it effectively prevents harmful clots, reduces clotting markers, and protects organs. Importantly, it achieves this without significantly increasing the risk of bleeding, making it a potentially safer option for sepsis patients with blood clot issues. Participants in this trial will join one of two cohorts, each receiving a titrated dose of BAY 3389934 as a continuous infusion for up to 96 hours.12345
Are You a Good Fit for This Trial?
This trial is for people in the ICU with sepsis (a severe infection causing organ problems) who also have blood clotting issues. They must meet certain lab criteria for low platelets or abnormal clotting and either be able to give consent or have a legal representative do so.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a titrated dose of BAY3389934 as a continuous infusion over up to 96 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events tracking
What Are the Treatments Tested in This Trial?
Interventions
- BAY 3389934
Trial Overview
The study is testing different doses of a new drug called BAY3389934 to see how safe it is and what dose works best for treating sepsis-induced coagulopathy. Participants are split into groups receiving increasing doses, with close monitoring over about 28 days.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.
Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Citations
A Potent and Selective Small-Molecule Dual Factor IIa/Xa ...
Sepsis-induced coagulopathy (SIC) is a severe and frequent complication of sepsis, which is associated with high mortality in patients.
Sepsis || Coagulopathy | Study 22265
A study to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy.
3.
pubs.acs.org
pubs.acs.org/jmcmar/article/68/12/12687/5203303/Discovery-of-BAY-3389934-Hydrochloride-A-PotentDiscovery of BAY 3389934 Hydrochloride: A Potent and ...
Sepsis-induced coagulopathy (SIC) is a severe and frequent complication of sepsis, which is associated with high mortality in patients.
BAY 3389934
BAY 3389934 is rapidly metabolised, providing short-acting anticoagulant effects with reduced bleeding risk. , makes it well-suited for IV ...
BAY 3389934 / Bayer
A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy … date: May 2026
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