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

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

De intervención

Fase

Fase 1

Rango de edad

18 años - 85 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

36 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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)

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

• 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.

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
• Participants with:

1. 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
2. Any hematological malignancy
3. 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

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

Sin asignación al azar

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (21)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

21 centros

Equipo y fechas

Patrocinador principal

Bayer

Inicio del estudio

12 mar 2025 Real

Finalización primaria

25 dic 2026 Estimado

Finalización del estudio

17 ene 2027 Estimado

Primera publicación

3 mar 2025 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio