SepsisPhase 1NCT06854640
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
A Phase 1 study testing BAY3389934 in people with Sepsis and Coagulopathy, run by Bayer at 21 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis, Coagulopathy
- What is being tested?
- BAY3389934
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 12 Mar 2025to 15 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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
- Any hematological malignancy
Show all 11Show fewer
- 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
Trial locations and contacts
21 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 5 countries
France7 sites, 7 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, Pays de la Loire Region, 49100
- Not yet recruiting
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, Île-de-France Region, 92380
- Recruiting
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, Pays de la Loire Region, 85000
- Recruiting
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, New Aquitaine, 87042
- Recruiting
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, Pays de la Loire Region, 44000
- Recruiting
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, Grand Est, 67091
- Not yet recruiting
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, Centre-Val de Loire, 37044
Netherlands5 sites, 5 recruiting
- Not yet recruiting
Jeroen Bosch Ziekenhuis - Intensive Care
's-Hertogenbosch, North Brabant, 5223 GZ
- Not yet recruiting
Medisch Spectrum Twente - Intensive Care
Enschede, Overijssel, 7512 KZ
- Not yet recruiting
Universitair Medisch Centrum St. Radboud - Intensive Care
Nijmegen, Gelderland, 6525 GA
- Not yet recruiting
Canisius WIlhelmina Ziekenhuis - Intensive Care
Nijmegen, Gelderland, 6532 SZ
- Not yet recruiting
Erasmus Medisch Centrum - Intensive Care
Rotterdam, South Holland, 3015 GD
Belgium4 sites, 4 recruiting
- Not yet recruiting
UZ Antwerpen - Intensive Care
Edegem, Antwerp, 2650
- Recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
Liège, 4000
- Recruiting
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies, Walloon Brabant, 1340
- Not yet recruiting
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
Woluwe-Saint-Lambert, Brussels Capital, 1200
Germany4 sites, 4 recruiting
- Not yet recruiting
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Cologne, North Rhine-Westphalia, 51109
- Recruiting
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, Saxony, 01307
- Not yet recruiting
Universitätsklinikum Leipzig AöR_Interdisziplinare Internistische Intensivmedizin
Leipzig, Saxony, 04103
- Not yet recruiting
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
München, Bavaria, 81377
United States1 site, 1 recruiting
- Not yet recruiting
UC Health University of Colorado Hospital - Medical Intensive Care Unit
Aurora, Colorado, 80045
About this study
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
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.
Read more
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)
- Conditions
- Sepsis, Coagulopathy
- Being tested
- BAY3389934
- Keywords
- DIC, Disseminated intravascular coagulation, Sepsis induced coagulopathy
- Medical subject headings
- Sepsis, Hemostatic Disorders, Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3389934Drug
Solution for IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 of BAY3389934 | Experimental | Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. Receives: Drug: BAY3389934 |
| Cohort 2 of BAY3389934 | Experimental | Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. Receives: Drug: BAY3389934 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with TEAEs (treatment-emergent adverse events)
Measured: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Severity of TEAEs
Measured: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Secondary outcomes (2)
Activated partial thromboplastin time (aPTT)
Measured: From the first administration of study intervention day 1 to day 6
Prothrombin time (PT)
Measured: From the first administration of study intervention day 1 to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start12 Mar 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854640
- Sponsor's protocol ID
- 22265
- Other IDs
- 2024-515635-30-00
- Status last verified
- 1 Oct 2026
- First submitted
- 28 Feb 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06854640
- Acronym / sponsor ID
- 22265
- Conditions
- Sepsis, Coagulopathy
- Keywords
- DIC, Disseminated intravascular coagulation, Sepsis induced coagulopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 of BAY3389934 | Experimental | Drug: BAY3389934Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. |
| Cohort 2 of BAY3389934 | Experimental | Drug: BAY3389934Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY3389934Solution for IV infusion | Drug | Cohort 1 of BAY3389934, Cohort 2 of BAY3389934 |
Primary outcome
The number of participants with TEAEs (treatment-emergent adverse events)
Time frame: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Severity of TEAEs
Time frame: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
2 secondary outcomes
Activated partial thromboplastin time (aPTT)
Time frame: From the first administration of study intervention day 1 to day 6
Prothrombin time (PT)
Time frame: From the first administration of study intervention day 1 to day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY3389934 in people with Sepsis and Coagulopathy, run by Bayer at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Netherlands, Belgium, Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact (188884229, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with TEAEs (treatment-emergent adverse events) (time frame: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.