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

Bayer

Status and phase: Suspended; Phase 1

Conditions: Coagulopathy; Sepsis

Treatments: Drug: BAY3389934

Study type: Interventional

Funder types: Industry

Identifiers

NCT06854640

22265 (Other Identifier)

2024-515635-30-00 (Registry Identifier)

Details and patient eligibility

About

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)

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be ≥ 18 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
• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Dose group 1 of BAY3389934

Experimental group

Description:

Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.

Treatment:

Drug: BAY3389934

Dose group 2 of BAY3389934

Experimental group

Description:

Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.

Treatment:

Drug: BAY3389934

Dose group 3 of BAY3389934

Experimental group

Description:

Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.

Treatment:

Drug: BAY3389934

Dose group 4 of BAY3389934

Experimental group

Description:

Subjects will receive Single dose of BAY3389934 as continuous infusion over up to 96 hours.

Treatment:

Drug: BAY3389934