search
Back to results

Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

Primary Purpose

Disseminated Intravascular Coagulation

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Antithrombin alfa (INN name)
Control (Standard treatment)
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disseminated Intravascular Coagulation focused on measuring DIC associated with severe sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent has been obtained from the patient or his/her legally acceptable representative
  • Severe sepsis
  • Disseminated intravascular coagulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    AT-150

    AT-250

    Control

    Arm Description

    Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%

    Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%

    The best standard treatment for the underlying condition only

    Outcomes

    Primary Outcome Measures

    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.
    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 Outcome Measures

    Mortality at Day 28
    Mortality at Day 90
    Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6
    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.
    Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6
    Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome
    Days Alive and Out of ICU Day 28
    Days alive and out of ICU at day 28 for all patients
    Days Alive and Out of Hospital Day 28
    Days alive and out of Hospital at day 28 for all patients
    Days Alive and Free of Inotrope/Vasopressor Support Day 28
    Days alive and free of inotrope/vasopressor at day 28 for all patients
    Days Alive and Off Ventilator Day 28
    Days alive and free of mechanical ventilation at day 28 for all patients
    Days Alive and Free of Need for Renal Replacement Therapy Day 28
    Days alive and out of renal replacement therapy at day 28 for all patients
    Change From Baseline to Day 6 in Inflammation Marker IL-6
    Change From Baseline to Day 6 in Inflammation Marker Procalcitonin

    Full Information

    First Posted
    July 23, 2007
    Last Updated
    August 5, 2021
    Sponsor
    LEO Pharma
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00506519
    Brief Title
    Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
    Official Title
    Exploratory Efficacy and Safety, Pharmacokinetics and Dose Finding Study of ATryn® (Antithrombin Alfa) in Patients With Disseminated Intravascular Coagulation Associated With Severe Sepsis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Terminated
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LEO Pharma

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disseminated Intravascular Coagulation
    Keywords
    DIC associated with severe sepsis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AT-150
    Arm Type
    Experimental
    Arm Description
    Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%
    Arm Title
    AT-250
    Arm Type
    Experimental
    Arm Description
    Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The best standard treatment for the underlying condition only
    Intervention Type
    Drug
    Intervention Name(s)
    Antithrombin alfa (INN name)
    Intervention Type
    Drug
    Intervention Name(s)
    Control (Standard treatment)
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    Day 28
    Secondary Outcome Measure Information:
    Title
    Mortality at Day 28
    Time Frame
    Day 28
    Title
    Mortality at Day 90
    Time Frame
    Day 90
    Title
    Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6
    Description
    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.
    Time Frame
    Baseline to Day 6
    Title
    Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6
    Description
    Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome
    Time Frame
    Baseline to Day 6
    Title
    Days Alive and Out of ICU Day 28
    Description
    Days alive and out of ICU at day 28 for all patients
    Time Frame
    Baseline to Day 28
    Title
    Days Alive and Out of Hospital Day 28
    Description
    Days alive and out of Hospital at day 28 for all patients
    Time Frame
    Baseline to Day 28
    Title
    Days Alive and Free of Inotrope/Vasopressor Support Day 28
    Description
    Days alive and free of inotrope/vasopressor at day 28 for all patients
    Time Frame
    Baseline to Day 28
    Title
    Days Alive and Off Ventilator Day 28
    Description
    Days alive and free of mechanical ventilation at day 28 for all patients
    Time Frame
    Baseline to Day 28
    Title
    Days Alive and Free of Need for Renal Replacement Therapy Day 28
    Description
    Days alive and out of renal replacement therapy at day 28 for all patients
    Time Frame
    Baseline to Day 28
    Title
    Change From Baseline to Day 6 in Inflammation Marker IL-6
    Time Frame
    Baseline to Day 6
    Title
    Change From Baseline to Day 6 in Inflammation Marker Procalcitonin
    Time Frame
    Baseline to Day 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent has been obtained from the patient or his/her legally acceptable representative Severe sepsis Disseminated intravascular coagulation

    12. IPD Sharing Statement

    Learn more about this trial

    Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

    We'll reach out to this number within 24 hrs