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Evaluating the safety and dosage of BAY 3389934 for treating 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

Phase 1 Interventional Bayer · NCT06854640

This study is testing a new medication called BAY 3389934 to see if it is safe and what the right dose is for people with blood clotting problems caused by sepsis.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment36 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorBayer Industry-sponsored
Locations20 sites (Edegem and 19 other locations)
Trial IDNCT06854640 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and appropriate dosage of BAY 3389934 in patients suffering from sepsis-induced coagulopathy. Sepsis occurs when an infection triggers an extreme immune response, leading to harmful blood clotting and potential organ damage. Participants will be enrolled from intensive care units and monitored for any medical issues during and after treatment with BAY 3389934. The study focuses on individuals who meet specific criteria related to sepsis and coagulopathy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with sepsis and coagulopathy, receiving treatment in an ICU.

Not a fit: Patients with clinically significant active bleeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with sepsis-induced coagulopathy, potentially reducing complications and mortality.

How similar studies have performed: While this approach is novel, previous studies have explored treatments for sepsis and coagulopathy, but the specific use of BAY 3389934 is untested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant must be ≥ 18 and ≤ 80 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
* Any 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

Where this trial is running

Edegem and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SepsisCoagulopathyDICDisseminated intravascular coagulationSepsis induced coagulopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.