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New drug aims to stop deadly clots in sepsis patients

NCT ID NCT06854640

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early study tests a new drug called BAY 3389934 in 36 hospital ICU patients with sepsis-induced coagulopathy, a condition where the body forms dangerous blood clots. The main goal is to check safety and find the right dose. Researchers will monitor side effects and blood clotting measures over 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BAY 3389934
What this could lead to
If this works, it could point toward a new treatment to control dangerous blood clotting in sepsis patients, potentially reducing organ damage and death.
What could go wrong
This is a very early Phase 1 trial with only 36 people, focused on safety and dosing. It is too soon to know if the drug will help, and there may be side effects or no benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

blood coagulation disease disseminated intravascular coagulation infectious disease with sepsis Sepsis vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coagulopathy Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation

    NOT_YET_RECRUITING

    Tours, Centre-Val de Loire, 37044, France

  • Canisius WIlhelmina Ziekenhuis - Intensive Care

    NOT_YET_RECRUITING

    Nijmegen, Gelderland, 6532 SZ, Netherlands

  • Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente

    RECRUITING

    La Roche-sur-Yon, Pays de la Loire Region, 85000, France

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

    RECRUITING

    Liège, 4000, Belgium

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

    RECRUITING

    Angers, Pays de la Loire Region, 49100, France

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

    RECRUITING

    Limoges, New Aquitaine, 87042, France

  • Clinique Saint-Pierre d'Ottignies - Intensive Care

    RECRUITING

    Ottignies, Walloon Brabant, 1340, Belgium

  • Erasmus Medisch Centrum - Intensive Care

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation

    NOT_YET_RECRUITING

    Nantes, Pays de la Loire Region, 44000, France

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

    RECRUITING

    Strasbourg, Grand Est, 67091, France

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

    NOT_YET_RECRUITING

    Garches, Île-de-France Region, 92380, France

  • Jeroen Bosch Ziekenhuis - Intensive Care

    NOT_YET_RECRUITING

    's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

  • Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

    NOT_YET_RECRUITING

    Cologne, North Rhine-Westphalia, 51109, Germany

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

    NOT_YET_RECRUITING

    München, Bavaria, 81377, Germany

  • Medisch Spectrum Twente - Intensive Care

    NOT_YET_RECRUITING

    Enschede, Overijssel, 7512 KZ, Netherlands

  • UZ Antwerpen - Intensive Care

    NOT_YET_RECRUITING

    Edegem, Antwerp, 2650, Belgium

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

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Universitair Medisch Centrum St. Radboud - Intensive Care

    NOT_YET_RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

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

    NOT_YET_RECRUITING

    Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

  • Universitätsklinikum Leipzig AöR_Interdisziplinare Internistische Intensivmedizin

    NOT_YET_RECRUITING

    Leipzig, Saxony, 04103, Germany

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