Actively Recruiting
First in Patient, Dose Escalation, Open Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion of BAY 3389934 to Patients With Sepsis Induced Coagulopathy
Led by Bayer · Updated on 2026-05-19
36
Participants Needed
20
Research Sites
7 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment for sepsis-induced coagulopathy, a condition where an infection causes an overactive immune response leading to harmful blood clots and low platelet levels. This condition can damage blood vessels and organs, sometimes resulting in death. The study aims to learn about the safety, suitable dose, and effects of the drug BAY 3389934 in patients receiving intensive care for sepsis-induced coagulopathy. Participants will receive BAY 3389934 as a continuous intravenous infusion over up to 96 hours. They will be divided into two groups: the first group receives a low starting dose which may be adjusted based on safety and tolerability, while the second group will receive a higher dose if the first group experiences no serious side effects. This phase 1 study focuses on carefully monitoring how the drug affects participants. During the approximately 28-day study period, doctors will collect blood and urine samples, perform physical exams, and monitor vital signs such as body temperature, blood pressure, and heart rate. Heart health will be assessed using electrocardiograms (ECG). Researchers will track any medical problems that occur during and after treatment to evaluate safety, including treatment-emergent adverse events and their severity. They will also measure blood clotting times from day 1 to day 6 to understand the drug’s effects.
CONDITIONS
Brief Title
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 to 80 years old at the time of signing informed consent
- Diagnosed with sepsis according to sepsis-3 criteria
- Suspected or documented origin of infection
- Coagulopathy defined by at least one of the following within 24 hours prior to study start: INR 21.40, platelet count between 21 30,000/mm3 and < 150,000/mm3, or greater than 30% decrease in platelets in 24 hours without other known cause; platelet count after decrease should not be < 30,000/mm3
- Receiving treatment in an intensive care unit (ICU)
- Informed consent given by capable participant or legal consent according to laws and regulations
You will not qualify if you...
- Active clinically significant bleeding or known bleeding disorder
- History of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or significant gastrointestinal bleeding within last 6 months
- Low platelet levels or abnormal coagulation from causes other than sepsis
- Need for therapeutic doses of anticoagulants or oral antiplatelet agents except low dose (≤100mg) acetyl salicylic acid
- Use of digoxin or metformin
- Any active malignancy
- Pregnancy or breastfeeding
- Chronic liver disease Child-Pugh Class C
- Major surgery or trauma with potential bleeding consequences within 28 days before study drug administration
- Neurotrauma, neurosurgery, or spine orthopedic surgery within 6 months before study drug administration
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 days
Participants receive titrated doses of BAY3389934 as a continuous intravenous infusion for up to 96 hours.
Continuous infusion over treatment period with monitoring visits during ICU stay
Trial Site Locations
Total: 20 locations
1
UZ Antwerpen - Intensive Care
Edegem, Belgium, 2650
Not Yet Recruiting
2
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
Liège, Belgium, 4000
Not Yet Recruiting
3
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, Belgium, 1340
Actively Recruiting
4
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
Woluwe-Saint-Lambert, Belgium, 1200
Not Yet Recruiting
5
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, Centre-Val de Loire, France, 37044
Not Yet Recruiting
6
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, Grand Est, France, 67091
Actively Recruiting
7
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, New Aquitaine, France, 87042
Not Yet Recruiting
8
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, Pays de la Loire Region, France, 49100
Not Yet Recruiting
9
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, Pays de la Loire Region, France, 85000
Not Yet Recruiting
10
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, Pays de la Loire Region, France, 44000
Not Yet Recruiting
11
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, Île-de-France Region, France, 92380
Not Yet Recruiting
12
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Cologne, North Rhine-Westphalia, Germany, 51109
Not Yet Recruiting
13
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, Germany, 01307
Not Yet Recruiting
14
Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin
Leipzig, Germany, 04103
Not Yet Recruiting
15
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
München, Germany, 81377
Not Yet Recruiting
16
Universitair Medisch Centrum St. Radboud - Intensive Care
Nijmegen, Gelderland, Netherlands, 6525 GA
Not Yet Recruiting
17
Canisius WIlhelmina Ziekenhuis - Intensive Care
Nijmegen, Gelderland, Netherlands, 6532 SZ
Not Yet Recruiting
18
Jeroen Bosch Ziekenhuis - Intensive Care
's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
Not Yet Recruiting
19
Medisch Spectrum Twente - Intensive Care
Enschede, Overijssel, Netherlands, 7512 KZ
Not Yet Recruiting
20
Erasmus Medisch Centrum - Intensive Care
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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