account_circleRecruiting
Sepsis, Coagulopathy
Bayer Identifier:
22265
ClinicalTrials.gov Identifier:
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)
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
AllAge
18 - N/ATrial summary
Enrollment Goal
32Trial Dates
March 2025 - April 2026Phase
Phase 1Could I Receive a placebo
NoProducts
BAY3389934Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care | Sint-Lambrechts-Woluwe, 1200, Belgium |
Not yet recruiting | Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation | Strasbourg, 67091, France |
Not yet recruiting | Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare | Garches, 92380, France |
Not yet recruiting | Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente | Limoges, 87042, France |
Not yet recruiting | Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation | Nantes, 44000, France |
Not yet recruiting | Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente | La Roche-Sur-Yon, 85000, France |
Not yet recruiting | Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare | Angers, 49100, France |
Not yet recruiting | CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation | Tours, 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 Haemostaseologie | Dresden, 01307, Germany |
Not yet recruiting | Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik | Köln, 51109, Germany |
Not yet recruiting | Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin | Leipzig, 04103, Germany |
Not yet recruiting | Universitair Medisch Centrum St. Radboud - Intensive Care | Nijmegen, 6525 GA, Netherlands |
Not yet recruiting | Medisch Spectrum Twente - Intensive Care | Enschede, 7512 KZ, Netherlands |
Not yet recruiting | Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care | Liege, 4000, Belgium |
Recruiting | Clinique Saint-Pierre d'Ottignies - Intensive Care | Ottignies-Louvain-La-Neuve, 1340, Belgium |
Not yet recruiting | UZ Antwerpen - Intensive Care | Edegem, 2650, Belgium |
Not yet recruiting | Erasmus Medisch Centrum - Intensive Care | Rotterdam, 3015 GD, Netherlands |
Not yet recruiting | Jeroen Bosch Ziekenhuis - Intensive Care | s-Hertogenbosch, 5223 GZ, Netherlands |
Not yet recruiting | Canisius WIlhelmina Ziekenhuis - Intensive Care | Nijmegen, 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 TEAEsdate_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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
4