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NCT06854640
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Phase 1 trial testing BAY3389934 in Sepsis in 36 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 36 |
| Start date | 12 March 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 28 February 2027 |
| Sites | 20 locations across Belgium, France, Netherlands, Germany |
Drugs / interventions tested
- BAY3389934 — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
- Coagulopathy — all drugs for Coagulopathy →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 80, any sex, with Sepsis or Coagulopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06854640
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06854640 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 27 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06854640.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing