Clinical trial NCT06854640: A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Sepsis
Coagulopathy
Keywords: DIC
Disseminated intravascular coagulation
Sepsis induced coagulopathy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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 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 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 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.
* 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), digoxin
* 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

Primary outcomes:
measure: The number of participants with TEAEs (treatment-emergent adverse events)
timeFrame: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
measure: Severity of TEAEs
timeFrame: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Secondary outcomes:
measure: Activated partial thromboplastin time (aPTT)
timeFrame: From the first administration of study intervention day 1 to day 6
measure: Prothrombin time (PT)
timeFrame: From the first administration of study intervention day 1 to day 6
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZ Antwerpen - Intensive Care
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
city: Ottignies-Louvain-La-Neuve
country: Belgium
facility: Clinique Saint-Pierre d'Ottignies - Intensive Care
city: Sint-Lambrechts-Woluwe
country: Belgium
facility: Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
city: Garches
country: France
facility: Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
city: La Roche-Sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
city: Nantes
country: France
facility: Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin
city: München
country: Germany
facility: Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente - Intensive Care
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St. Radboud - Intensive Care
city: Nijmegen
country: Netherlands
facility: Canisius WIlhelmina Ziekenhuis - Intensive Care
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum - Intensive Care
city: s-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis - Intensive Care
Study officials:
References: