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NCT06854640From ClinicalTrials.govRecruiting

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

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

  • Sepsis
  • Coagulopathy

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Bayer
Enrolment target
36
Started
12 March 2025
Main results due
25 December 2026
Study sites
21
Registry updated
23 September 2026

Can you take part?

  • Ages 18 years to 85 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Participant must be ≥ 18 and ≤ 85 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, metformin
* Participants with:

  1. Uncontrolled malignancy requiring ongoing chemotherapy, radiation therapy, or immunotherapy within the past 6 months with the exception of: low-risk localized prostate cancer (Gleason score is equal to or less than 6 AND Prostate- Specific Antigen is below 10 ng/mL); or cervical carcinoma in situ; or ductal carcinoma in situ; or adequately treated non-metastatic squamous cell skin carcinoma; or adequately treated basal cell skin carcinoma. Patients with breast or prostate cancer receiving single endocrine (hormonal) therapy are eligible if all other cancer-directed treatments were completed more than 6 months prior to screening
  2. Any hematological malignancy
  3. Any active or prior malignancy involving the central nervous system (brain or spinal cord), including primary tumors or metastases.
* 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

What this study is about

In the sponsor’s own words, from the registry.

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 divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934.

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)

Study sites(21)

  • UC Health University of Colorado Hospital - Medical Intensive Care Unit

    Aurora, Colorado, United States

    Not yet recruiting

  • UZ Antwerpen - Intensive Care

    Edegem, Antwerp, Belgium

    Not yet recruiting

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

    Woluwe-Saint-Lambert, Brussels Capital, Belgium

    Not yet recruiting

  • Clinique Saint-Pierre d'Ottignies - Intensive Care

    Ottignies, Walloon Brabant, Belgium

    Recruiting

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

    Liège, Belgium

    Recruiting

  • CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation

    Tours, Centre-Val de Loire, France

    Not yet recruiting

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

    Strasbourg, Grand Est, France

    Recruiting

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

    Limoges, New Aquitaine, France

    Recruiting

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

    Angers, Pays de la Loire Region, France

    Recruiting

  • Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente

    La Roche-sur-Yon, Pays de la Loire Region, France

    Recruiting

  • Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation

    Nantes, Pays de la Loire Region, France

    Recruiting

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

    Garches, Île-de-France Region, France

    Not yet recruiting

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

    München, Bavaria, Germany

    Not yet recruiting

  • Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

    Cologne, North Rhine-Westphalia, Germany

    Not yet recruiting

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

    Dresden, Saxony, Germany

    Recruiting

  • Universitätsklinikum Leipzig AöR_Interdisziplinare Internistische Intensivmedizin

    Leipzig, Saxony, Germany

    Not yet recruiting

  • Universitair Medisch Centrum St. Radboud - Intensive Care

    Nijmegen, Gelderland, Netherlands

    Not yet recruiting

  • Canisius WIlhelmina Ziekenhuis - Intensive Care

    Nijmegen, Gelderland, Netherlands

    Not yet recruiting

  • Jeroen Bosch Ziekenhuis - Intensive Care

    's-Hertogenbosch, North Brabant, Netherlands

    Not yet recruiting

  • Medisch Spectrum Twente - Intensive Care

    Enschede, Overijssel, Netherlands

    Not yet recruiting

  • Erasmus Medisch Centrum - Intensive Care

    Rotterdam, South Holland, Netherlands

    Not yet recruiting

Showing 21 of 21 sites. 8 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06854640. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Se | Trialion