A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy

NCT06854640 | Recruiting Phase 1 DMC

• 2 other identifiers: 222652024-515635-30-00
• Study Type: interventional
• Target: 36
• Locations: 4 countries
• Sites: 20

Brief Summary

Researchers are looking for a better way to treat people who have sepsis induced coagulopathy. Sepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death. The main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU). For this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Participants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934. Each participant will be in the study for around 28 days. During the study, the doctors and their study team will:

• Take blood and urine samples,
• Do physical examinations,
• Check vital signs such as body temperature, blood pressure and heart rate,
• Examine heart health using electrocardiogram (ECG)

Conditions

Sepsis; Coagulopathy

Keywords

DIC; Disseminated intravascular coagulation; Sepsis induced coagulopathy

Outcome Measures

Primary Outcomes (2)

• The number of participants with TEAEs (treatment-emergent adverse events)

  After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours

• Severity of TEAEs

  After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours

Secondary Outcomes (2)

• Activated partial thromboplastin time (aPTT)

  From the first administration of study intervention day 1 to day 6

• Prothrombin time (PT)

  From the first administration of study intervention day 1 to day 6

Study Arms (2)

Cohort 1 of BAY3389934

EXPERIMENTAL

Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.

Drug: BAY3389934

Cohort 2 of BAY3389934

EXPERIMENTAL

Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.

Drug: BAY3389934

Interventions

BAY3389934 DRUG

Solution for IV infusion

Cohort 1 of BAY3389934; Cohort 2 of BAY3389934

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.
• Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
• participants with suspected or documented origin of infection.
• Participants with coagulopathy defined by at least one of the following within 24 hours prior start of study intervention: INR ≥1.40, platelet count in the range of ≥ 30,000/mm3 to \< 150,000/mm3 OR greater than 30% decrease in platelets in 24 hours without other known etiology. The platelet count after decrease should not be \< 30,000/mm3.
• Participants must be receiving treatment in an ICU.

You may not qualify if:

• Clinically significant active bleeding; known bleeding disorder, history of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months.
• Low platelets level or abnormal coagulation status due to any other reason than sepsis.
• Participants with indication for therapeutic dose of: anticoagulation (heparin, argatroban, vitamin K antagonists/warfarin, dabigatran, apixaban, rivaroxaban, edoxaban), oral antiplatelet agents (clopidogrel, ticagrelor, ticlopidine, prasugrel) except low dose (≤100mg) acetyl salicylic acid (ASA), digoxin, metformin
• Any active malignancy
• Pregnancy or breastfeeding.
• Chronic liver disease Child-Pugh Class C.
• Participants experienced major surgery or major trauma (intrathoracic, intra-abdominal, pelvic or femur) or surgery/trauma in any other area with potentially clinically significant consequences due to bleeding within 28 days before study drug administration.
• Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedic surgery in spine within 6 months before study drug administration

Sponsors & Collaborators

• Bayer: lead

Study Sites (20)

UZ Antwerpen - Intensive Care

Edegem, 2650, Belgium

NOT YET RECRUITING

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care

Liège, 4000, Belgium

NOT YET RECRUITING

Clinique Saint-Pierre d'Ottignies - Intensive Care

Ottignies-Louvain-la-Neuve, 1340, Belgium

RECRUITING

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care

Woluwe-Saint-Lambert, 1200, Belgium

NOT YET RECRUITING

CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation

Tours, Centre-Val de Loire, 37044, France

NOT YET RECRUITING

Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation

Strasbourg, Grand Est, 67091, France

RECRUITING

Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente

Limoges, New Aquitaine, 87042, France

NOT YET RECRUITING

Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare

Angers, Pays de la Loire Region, 49100, France

NOT YET RECRUITING

Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente

La Roche-sur-Yon, Pays de la Loire Region, 85000, France

NOT YET RECRUITING

Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation

Nantes, Pays de la Loire Region, 44000, France

NOT YET RECRUITING

Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare

Garches, Île-de-France Region, 92380, France

NOT YET RECRUITING

Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

Cologne, North Rhine-Westphalia, 51109, Germany

NOT YET RECRUITING

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie

Dresden, 01307, Germany

NOT YET RECRUITING

Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin

Leipzig, 04103, Germany

NOT YET RECRUITING

Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)

München, 81377, Germany

NOT YET RECRUITING

Universitair Medisch Centrum St. Radboud - Intensive Care

Nijmegen, Gelderland, 6525 GA, Netherlands

NOT YET RECRUITING

Canisius WIlhelmina Ziekenhuis - Intensive Care

Nijmegen, Gelderland, 6532 SZ, Netherlands

NOT YET RECRUITING

Jeroen Bosch Ziekenhuis - Intensive Care

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

NOT YET RECRUITING

Medisch Spectrum Twente - Intensive Care

Enschede, Overijssel, 7512 KZ, Netherlands

NOT YET RECRUITING

Erasmus Medisch Centrum - Intensive Care

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis; Hemostatic Disorders; Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders; Thrombophilia

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 3, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); DE (4); FR (7); NL (5)