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16mg,KB for Sepsis

Phase 2
Recruiting
Research Sponsored by Tianjin Chasesun Pharmaceutical Co., LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2, 4 , 8 after the first dose (within 24 hours after the last dose on day 7)

Summary

Phase II study of Kukoamine B Mesilate in Sepsis Patients

Eligible Conditions
  • Sepsis
  • Staphylococcal Sepsis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8 after the first dose (within 24 hours after the last dose on day 7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 after the first dose (within 24 hours after the last dose on day 7) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Clinical Outcome Composite Endpoint
Delta SOFA (ΔSOFA)
Duration of ICU stay and absence
+5 more
Other study objectives
Area under the curve at steady state (AUCss)
Correlation between the exposure of Kukoamine B Mesilate and hepatic-related treatment-related adverse events
Correlation between the exposure of Kukoamine B Mesilate and its efficacy
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 16mg,KBExperimental Treatment1 Intervention
Group A:16mg,Q8h±3min,Day1-Day7
Group II: PlacebosPlacebo Group1 Intervention
Group B:Placebos,Q8h±3min,Day1-Day7

Find a Location

Who is running the clinical trial?

Tianjin Chasesun Pharmaceutical Co., LTDLead Sponsor
4 Previous Clinical Trials
216 Total Patients Enrolled
1 Trials studying Sepsis
44 Patients Enrolled for Sepsis
Southwest Hospital, ChinaOTHER
140 Previous Clinical Trials
143,571 Total Patients Enrolled
2 Trials studying Sepsis
104 Patients Enrolled for Sepsis
~94 spots leftby Nov 2025
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