Evaluating the safety and dosage of BAY 3389934 for treating sepsis-induced coagulopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and appropriate dosage of BAY 3389934 in patients suffering from sepsis-induced coagulopathy. Sepsis occurs when an infection triggers an extreme immune response, leading to harmful blood clotting and potential organ damage. Participants will be enrolled from intensive care units and monitored for any medical issues during and after treatment with BAY 3389934. The study focuses on individuals who meet specific criteria related to sepsis and coagulopathy.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinique Saint-Pierre d'Ottignies - Intensive Care
  Ottignies, Walloon Brabant, Belgium Recruiting
• Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
  Liège, Belgium Recruiting
• Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
  Strasbourg, Grand Est, France Recruiting
• Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
  Limoges, New Aquitaine, France Recruiting
• Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
  Angers, Pays de la Loire Region, France Recruiting
• Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
  La Roche-sur-Yon, Pays de la Loire Region, France Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 188884229

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.