A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBayer
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
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
Trial design
Design model
Sequential
Treatments tested in this trial
BAY3389934
DrugSolution for IV infusion
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Cohort 1 of BAY3389934Experimental treatment 1 intervention
Group B: Cohort 2 of BAY3389934Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of participants with TEAEs (treatment-emergent adverse events)
Time frame
After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours2
Severity of TEAEs
Time frame
After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hoursSecondary outcomes
1
Activated partial thromboplastin time (aPTT)
Time frame
From the first administration of study intervention day 1 to day 62
Prothrombin time (PT)
Time frame
From the first administration of study intervention day 1 to day 6 Source ClinicalTrials.gov