Phase 3
N=816
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
Severe Sepsis · Coagulopathy
Bottom Line
View on ClinicalTrials.gov: NCT01598831 ↗Enrolled (actual)
816
Serious AEs
51.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With 28-Day All-cause Mortality — 106; 119 Participants — p=0.318
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ART-123 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asahi Kasei Pharma America Corporation
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 28-Day All-cause Mortality |
106; 119 | 0.318 |
| PRIMARY Number of Participants With On-Treatment Serious Major Bleeding Events |
23; 16 | — |
| SECONDARY Follow up All-cause Mortality at 3 Months |
126; 136 | — |
| SECONDARY Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction |
17.6; 17.6; 15.8; 14.5; 20.2; 19.6 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies |
0; 0 | — |
Summary
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
Eligibility Criteria
Inclusion Criteria
- Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, RR)
- Clinical objective evidence of bacterial infection and a known site of infection.
- Cardiovascular dysfunction or Respiratory Failure due to sepsis.
- Coagulopathy characterized by an INR >1.40 without other known causes.
Exclusion Criteria
- Subject or Authorized Representative is unable to provide informed consent.
- Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study.
- Subject is of childbearing potential and does not have a negative pregnancy test.
- Subject is 48 hours prior to first dose of study drug whether receiving RRT or not
- Use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 72 hours prior to first does of study drug.
- Life expectancy < 90 days.
- Current use of any chemotherapy agent likely to cause myeloablation (severe or complete depletion of bone marrow).
- Participation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization.
- Confirmed or suspected endocarditis
Data sourced from ClinicalTrials.gov (NCT01598831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.