A study to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis and coagulopathy

Phase 1

Suspended

• Conditions: Coagulopathy; Sepsis
• Interventions: Drug: BAY3389934

• Registration Number: 2024-515635-30-00
• Lead Sponsor: Bayer AG

Brief 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. 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 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-03
• Study Start: 2025-03-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-29
• Primary Completion: 2026-03-16
• Study Completion: 2026-05-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose group 1 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.
Dose group 4 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.
Dose group 3 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.
Dose group 2 of BAY3389934	BAY3389934	Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.

Primary Outcome Measures

Name	Time	Method
The number of participants with TEAEs (treatment-emergent adverse events)	After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Severity of TEAEs	After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours

Secondary Outcome Measures

Name	Time	Method
Activated partial thromboplastin time (aPTT)	From the first administration of study intervention day 1 to day 6
Prothrombin time (PT)	From the first administration of study intervention day 1 to day 6

Trial Locations

Locations (20)

UZ Antwerpen - Intensive Care; 🇧🇪 Edegem, Belgium

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care; 🇧🇪 Liege, Belgium

Clinique Saint-Pierre d'Ottignies - Intensive Care; 🇧🇪 Ottignies-Louvain-La-Neuve, Belgium

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care; 🇧🇪 Sint-Lambrechts-Woluwe, Belgium

Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare; 🇫🇷 Angers, France

Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare; 🇫🇷 Garches, France

Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente; 🇫🇷 La Roche-Sur-Yon, France

Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente; 🇫🇷 Limoges, France

Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation; 🇫🇷 Nantes, France

Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation; 🇫🇷 Strasbourg, France

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