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

Phase 1

Recruiting

• Conditions: Sepsis; Coagulopathy
• Interventions: Drug: BAY3389934

• Registration Number: NCT06854640
• Lead Sponsor: Bayer

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 human 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 equally divided into different groups. The first group will receive the lowest dose of BAY 3389934. If researchers consider this dose to be safe, the next group of participants will receive a higher dose until the researchers find a suitable dose of BAY 3389934.

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-03
• Study Start: 2025-03-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-03-13
• Study Completion: 2026-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Participant must be ≥ 18 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 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.
• Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.

Exclusion Criteria

• 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).
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose group 1 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.
Dose group 4 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.
Dose group 3 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.
Dose group 2 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

UZ Antwerpen - Intensive Care; 🇧🇪 Edegem, Belgium

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care; 🇧🇪 Liege, Belgium

Clinique Saint-Pierre d'Ottignies - Intensive Care; 🇧🇪 Ottignies-Louvain-La-Neuve, Belgium

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care; 🇧🇪 Sint-Lambrechts-Woluwe, Belgium

Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare; 🇫🇷 Angers, France

Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare; 🇫🇷 Garches, France

Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente; 🇫🇷 La Roche-Sur-Yon, France

Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente; 🇫🇷 Limoges, France

Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation; 🇫🇷 Nantes, France

Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation; 🇫🇷 Strasbourg, France

CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation; 🇫🇷 Tours, France

Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie; 🇩🇪 Dresden, Germany

Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin; 🇩🇪 Leipzig, Germany

Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern); 🇩🇪 München, Germany

Medisch Spectrum Twente - Intensive Care; 🇳🇱 Enschede, Netherlands

Universitair Medisch Centrum St. Radboud - Intensive Care; 🇳🇱 Nijmegen, Netherlands

Canisius WIlhelmina Ziekenhuis - Intensive Care; 🇳🇱 Nijmegen, Netherlands

Erasmus Medisch Centrum - Intensive Care; 🇳🇱 Rotterdam, Netherlands

Jeroen Bosch Ziekenhuis - Intensive Care; 🇳🇱 s-Hertogenbosch, Netherlands