Exploratory Efficacy and Safety, Pharmacokinetics and Dose Finding Study of ATryn® (Antithrombin Alfa) in Patients With Disseminated Intravascular Coagulation Associated With Severe Sepsis
Overview
- Phase
- Phase 2
- Intervention
- Antithrombin alfa (INN name)
- Conditions
- Disseminated Intravascular Coagulation
- Sponsor
- LEO Pharma
- Enrollment
- 25
- Primary Endpoint
- Patients Alive on Day 28, Having Had an Improvement in the DIC Score (Overt or Non-overt) by at Least 2 Points Between Baseline and Day 6 and Having Had no Worsening of the SOFA Score Between Baseline and Day 6.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent has been obtained from the patient or his/her legally acceptable representative
- •Severe sepsis
- •Disseminated intravascular coagulation
Exclusion Criteria
- Not provided
Arms & Interventions
AT-150
Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%
Intervention: Antithrombin alfa (INN name)
AT-250
Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%
Intervention: Antithrombin alfa (INN name)
Control
The best standard treatment for the underlying condition only
Intervention: Control (Standard treatment)
Outcomes
Primary Outcomes
Patients Alive on Day 28, Having Had an Improvement in the DIC Score (Overt or Non-overt) by at Least 2 Points Between Baseline and Day 6 and Having Had no Worsening of the SOFA Score Between Baseline and Day 6.
Time Frame: Day 28
Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome. Sepsis-related Organ Failure Assessment (SOFA) is a composite score of scores for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 to 4 with a higher score given for worse organ function. The scores are then added together to give a total range from 0 to 24 with a higher score representing a worse outcome.
Secondary Outcomes
- Days Alive and Out of Hospital Day 28(Baseline to Day 28)
- Days Alive and Free of Inotrope/Vasopressor Support Day 28(Baseline to Day 28)
- Days Alive and Off Ventilator Day 28(Baseline to Day 28)
- Days Alive and Free of Need for Renal Replacement Therapy Day 28(Baseline to Day 28)
- Change From Baseline to Day 6 in Inflammation Marker IL-6(Baseline to Day 6)
- Change From Baseline to Day 6 in Inflammation Marker Procalcitonin(Baseline to Day 6)
- Mortality at Day 28(Day 28)
- Mortality at Day 90(Day 90)
- Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6(Baseline to Day 6)
- Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6(Baseline to Day 6)
- Days Alive and Out of ICU Day 28(Baseline to Day 28)