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Sepsis, Coagulopathy

Bayer Identifier:

22265

ClinicalTrials.gov Identifier:

NCT06854640

EudraCT Number:

Not Available

EU CT Number:

2024-515635-30-00
A study to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy

Trial purpose

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)

Key Participants Requirements

Sex

All

Age

18 - N/A
  • -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.
  • -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

Trial summary

Enrollment Goal
32
Trial Dates
March 2025 - April 2026
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY3389934
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive CareSint-Lambrechts-Woluwe, 1200, Belgium
Not yet recruiting
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive RéanimationStrasbourg, 67091, France
Not yet recruiting
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine HyperbareGarches, 92380, France
Not yet recruiting
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalenteLimoges, 87042, France
Not yet recruiting
Hopital Hotel Dieu Nantes - Service de Médecine Intensive RéanimationNantes, 44000, France
Not yet recruiting
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalenteLa Roche-Sur-Yon, 85000, France
Not yet recruiting
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine HyperbareAngers, 49100, France
Not yet recruiting
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive RéanimationTours, 37044, France
Not yet recruiting
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)München, 81377, Germany
Not yet recruiting
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB HaemostaseologieDresden, 01307, Germany
Not yet recruiting
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - LungenklinikKöln, 51109, Germany
Not yet recruiting
Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische IntensivmedizinLeipzig, 04103, Germany
Not yet recruiting
Universitair Medisch Centrum St. Radboud - Intensive CareNijmegen, 6525 GA, Netherlands
Not yet recruiting
Medisch Spectrum Twente - Intensive CareEnschede, 7512 KZ, Netherlands
Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive CareLiege, 4000, Belgium
Recruiting
Clinique Saint-Pierre d'Ottignies - Intensive CareOttignies-Louvain-La-Neuve, 1340, Belgium
Not yet recruiting
UZ Antwerpen - Intensive CareEdegem, 2650, Belgium
Not yet recruiting
Erasmus Medisch Centrum - Intensive CareRotterdam, 3015 GD, Netherlands
Not yet recruiting
Jeroen Bosch Ziekenhuis - Intensive Cares-Hertogenbosch, 5223 GZ, Netherlands
Not yet recruiting
Canisius WIlhelmina Ziekenhuis - Intensive CareNijmegen, 6532 SZ, Netherlands

Primary Outcome

  • The number of participants with TEAEs (treatment-emergent adverse events)
    date_rangeTime Frame:
    After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
  • Severity of TEAEs
    date_rangeTime Frame:
    After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours

Secondary Outcome

  • Activated partial thromboplastin time (aPTT)
    date_rangeTime Frame:
    From the first administration of study intervention day 1 to day 6
  • Prothrombin time (PT)
    date_rangeTime Frame:
    From the first administration of study intervention day 1 to day 6

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
4

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.