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

StatusRecruiting
PhasePhase 1
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 20 to 21 Eligibility criteria expanded, about 129 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 129 words
  2. Completion date: Feb 15, 2027 to Jan 17, 2027 Study sites revised (20)v12 Show 1 more changeShow less
    • Study sites revised (20)

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 5 of 20 sitesv11
  4. Site details revised at 1 of 20 sitesv10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Dec 31, 2026 to Dec 25, 2026 Completion date: Feb 28, 2027 to Feb 15, 2027 · Site details revised at 5 of 20 sitesv8 Show 2 more changesShow less
    • Completion date: Feb 28, 2027 to Feb 15, 2027
    • Site details revised at 5 of 20 sites
  2. Trial status: Suspended to Recruiting Primary completion date: Mar 16, 2026 to Dec 31, 2026 · Enrollment target: 32 to 36 · Completion date: May 10, 2026 to Feb 28, 2027 · 3 morev7 Show 6 more changesShow less
    • Primary completion date: Mar 16, 2026 to Dec 31, 2026
    • Enrollment target: 32 to 36
    • Completion date: May 10, 2026 to Feb 28, 2027
    • Site details revised at 20 of 20 sites
    • Study arms: 4 to 2
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Suspended Sponsor's reason: Patient safety concern based on difficulty for investigator to assess coagulation status of patient. Reference is made to the Unexpected… Site details revised at 20 of 20 sitesv6 Show 1 more changeShow less
    • Site details revised at 20 of 20 sites
  4. Primary completion date: Mar 13, 2026 to Mar 16, 2026 Completion date: Apr 10, 2026 to May 10, 2026 · Eligibility criteria expanded, about 3 wordsv5 Show 2 more changesShow less
    • Completion date: Apr 10, 2026 to May 10, 2026
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 20 sitesv4
  6. Re-verified, no change to tracked fieldsv3
  7. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 10, 2025 to Mar 12, 2025 · Study sites revised (20)v2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 10, 2025 to Mar 12, 2025
    • Study sites revised (20)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bayer
131 trials monitored
See 7 trials at risk
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)
Trial Details
NCT Number NCT06854640
Lead Sponsor Bayer
Conditions Sepsis, Coagulopathy
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov