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

Last updated: May 2, 2025
Sponsor: Bayer
Overall Status: Active - Recruiting

Phase

1

Condition

Soft Tissue Infections

Blood Clots

Treatment

BAY3389934

Clinical Study ID

NCT06854640
22265
2024-515635-30-00
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 definedas life-threatening organ dysfunction caused by a dysregulated host response toinfection.

  • participants with suspected origin of infection.

  • Participants with coagulopathy defined by at least one of the following within 24hours 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 hourswithout 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 incapableof giving informed consent, consent for study inclusion will be sought according toapplicable laws and regulations.

Exclusion

Exclusion Criteria:

  • Clinically significant active bleeding; known bleeding disorder, history of majortraumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) orclinically significant gastrointestinal bleeding within last 6 months.

  • Low platelets level or abnormal coagulation status due to any other reason thansepsis.

  • 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 withpotentially clinically significant consequences due to bleeding within 28 daysbefore study drug administration.

  • Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedicsurgery in spine within 6 months before study drug administration

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: BAY3389934
Phase: 1
Study Start date:
March 12, 2025
Estimated Completion Date:
April 10, 2026

Connect with a study center

  • UZ Antwerpen - Intensive Care

    Edegem, 2650
    Belgium

    Site Not Available

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

    Liege, 4000
    Belgium

    Site Not Available

  • Clinique Saint-Pierre d'Ottignies - Intensive Care

    Ottignies-Louvain-La-Neuve, 1340
    Belgium

    Active - Recruiting

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

    Sint-Lambrechts-Woluwe, 1200
    Belgium

    Site Not Available

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

    Angers, 49100
    France

    Site Not Available

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

    Garches, 92380
    France

    Site Not Available

  • Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente

    La Roche-Sur-Yon, 85000
    France

    Site Not Available

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

    Limoges, 87042
    France

    Site Not Available

  • Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation

    Nantes, 44000
    France

    Site Not Available

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

    Strasbourg, 67091
    France

    Active - Recruiting

  • CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation

    Tours, 37044
    France

    Site Not Available

  • Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

    Köln, Nordrhein-Westfalen 51109
    Germany

    Site Not Available

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

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin

    Leipzig, 04103
    Germany

    Site Not Available

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

    München, 81377
    Germany

    Site Not Available

  • LMU Klinikum der Universität München Campus Innenstadt - Klink für Anaestheseologie

    München, 80336
    Germany

    Site Not Available

  • Medisch Spectrum Twente - Intensive Care

    Enschede, 7512 KZ
    Netherlands

    Site Not Available

  • Canisius WIlhelmina Ziekenhuis - Intensive Care

    Nijmegen, 6532 SZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum St. Radboud - Intensive Care

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum - Intensive Care

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis - Intensive Care

    s-Hertogenbosch, 5223 GZ
    Netherlands

    Site Not Available

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