A Phase 2 interventional study of Antithrombin alfa (INN name) and Control (Standard treatment) in Disseminated Intravascular Coagulation, sponsored by LEO Pharma. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by LEO Pharma · Phase 2, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 25 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
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Inclusion Criteria:
Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%
Drug: Antithrombin alfa (INN name)
Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%
Drug: Antithrombin alfa (INN name)
The best standard treatment for the underlying condition only
Drug: Control (Standard treatment)
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.
Time frame: Day 28
Mortality at Day 28
Time frame: Day 28
Mortality at Day 90
Time frame: 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.
Time frame: Baseline to Day 6
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
Time frame: Baseline to Day 6
Days Alive and Out of ICU Day 28
Days alive and out of ICU at day 28 for all patients
Time frame: Baseline to Day 28
Days Alive and Out of Hospital Day 28
Days alive and out of Hospital at day 28 for all patients
Time frame: Baseline to Day 28
Days Alive and Free of Inotrope/Vasopressor Support Day 28
Days alive and free of inotrope/vasopressor at day 28 for all patients
Time frame: Baseline to Day 28
Days Alive and Off Ventilator Day 28
Days alive and free of mechanical ventilation at day 28 for all patients
Time frame: Baseline to Day 28
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
Time frame: Baseline to Day 28
Change From Baseline to Day 6 in Inflammation Marker IL-6
Time frame: Baseline to Day 6
Change From Baseline to Day 6 in Inflammation Marker Procalcitonin
Time frame: Baseline to Day 6
| Milestone | AT-150 | AT-250 | Control |
|---|---|---|---|
| Started | 10 | 10 | 5 |
| Completed treatment (day 5) | 8 | 7 | 5 |
| Day 28 follow up | 8 | 6 | 5 |
| Completed | 5 | 4 | 5 |
| Not completed | 5 | 6 | 0 |
| Withdrew: Death | 4 | 6 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
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.
| Participants | AT-150 | AT-250 | Control |
|---|---|---|---|
| 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. | 2 | 2 | 2 |
| Participants | AT-150 | AT-250 | Control |
|---|---|---|---|
| Mortality at Day 28 | 1 | 4 | 0 |
| Participants | AT-150 | AT-250 | Control |
|---|---|---|---|
| Mortality at Day 90 | 4 | 6 | 0 |
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.
| score on a scale | AT-150 | AT-250 | Control |
|---|---|---|---|
| Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6 | -0.2 ± 1.2 | -0.3 ± 1.5 | 0.2 ± 1.1 |
Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome
| score on a scale | AT-150 | AT-250 | Control |
|---|---|---|---|
| Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6 | -3.0 ± 1.7 | -2.2 ± 2.4 | -3.0 ± 1.6 |
Days alive and out of ICU at day 28 for all patients
| Days | AT-150 | AT-250 | Control |
|---|---|---|---|
| Days Alive and Out of ICU Day 28 | 9.8 ± 10.8 | 4.7 ± 10.0 | 13.6 ± 8.4 |
Days alive and out of Hospital at day 28 for all patients
| Days | AT-150 | AT-250 | Control |
|---|---|---|---|
| Days Alive and Out of Hospital Day 28 | 3.0 ± 6.4 | 3.0 ± 6.6 | 4.6 ± 7.4 |
Days alive and free of inotrope/vasopressor at day 28 for all patients
| Days | AT-150 | AT-250 | Control |
|---|---|---|---|
| Days Alive and Free of Inotrope/Vasopressor Support Day 28 | 20.7 ± 9.0 | 12.4 ± 11.7 | 21.6 ± 6.8 |
Days alive and free of mechanical ventilation at day 28 for all patients
| Days | AT-150 | AT-250 | Control |
|---|---|---|---|
| Days Alive and Off Ventilator Day 28 | 11.4 ± 10.5 | 8.9 ± 11.8 | 14.4 ± 8.8 |
Days alive and out of renal replacement therapy at day 28 for all patients
| Days | AT-150 | AT-250 | Control |
|---|---|---|---|
| Days Alive and Free of Need for Renal Replacement Therapy Day 28 | 22.6 ± 13.3 | 10.5 ± 13.4 | 23.0 ± 6.9 |
| pg/mL | AT-150 | AT-250 | Control |
|---|---|---|---|
| Change From Baseline to Day 6 in Inflammation Marker IL-6 | -68429 ± 192828 | -13153 ± 31801 | -69651 ± 141889 |
| ng/mL | AT-150 | AT-250 | Control |
|---|---|---|---|
| Change From Baseline to Day 6 in Inflammation Marker Procalcitonin | -203.8 ± 340.2 | -51.1 ± 49.6 | -139.6 ± 146.2 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AT-150 | 4/10 (40%) | 5/10 (50%) | 10/10 (100%) |
| AT-250 | 6/10 (60%) | 8/10 (80%) | 10/10 (100%) |
| Control | 0/5 (0%) | 5/5 (100%) | 5/5 (100%) |
| Event | AT-150 | AT-250 | Control |
|---|---|---|---|
| Puncture site haemorrhageGeneral disorders | 1/10 | 0/10 | 3/5 |
| HaemorrhageVascular disorders | 2/10 | 3/10 | 2/5 |
| Tracheal haemorrhageBlood and lymphatic system disorders | 0/10 | 3/10 | 1/5 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 1/10 | 0/10 | 1/5 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/10 | 2/10 | 1/5 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/10 | 0/10 | 1/5 |
| Tooth injuryInjury, poisoning and procedural complications | 0/10 | 0/10 | 1/5 |
| WoundInjury, poisoning and procedural complications | 0/10 | 0/10 | 1/5 |
| NecrosisGeneral disorders | 0/10 | 0/10 | 1/5 |
| Catheter site dischargeGeneral disorders | 0/10 | 0/10 | 1/5 |
| Event | AT-150 | AT-250 | Control |
|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 1/10 | 0/10 | 3/5 |
| AnaemiaBlood and lymphatic system disorders | 1/10 | 4/10 | 1/5 |
| OedemaGeneral disorders | 0/10 | 0/10 | 2/5 |
| HypokalaemiaMetabolism and nutrition disorders | 0/10 | 0/10 | 2/5 |
| Puncture site heamorrhageGeneral disorders | 1/10 | 0/10 | 2/5 |
| HaemorrhageVascular disorders | 1/10 | 1/10 | 2/5 |
| PneumoniaInfections and infestations | 3/10 | 2/10 | 0/5 |
| HypotensionVascular disorders | 3/10 | 1/10 | 0/5 |
| LeukocytosisBlood and lymphatic system disorders | 0/10 | 0/10 | 1/5 |
| CyanosisCardiac disorders | 0/10 | 0/10 | 1/5 |
| Age, Continuous(years) | AT-150 | AT-250 | Control | Total |
|---|---|---|---|---|
| Mean | 57 ± 16.6 | 65.5 ± 19.4 | 58 ± 22.9 | 60.6 ± 18.7 |
| Sex: Female, Male(Participants) | AT-150 | AT-250 | Control | Total |
|---|---|---|---|---|
| Female | 8 | 4 | 4 | 16 |
| Male | 2 | 6 | 1 | 9 |
| Race/Ethnicity, Customized(Participants) | AT-150 | AT-250 | Control | Total |
|---|---|---|---|---|
| Ethnic origin — Caucasian | 8 | 10 | 5 | 23 |
| Ethnic origin — Asian | 2 | 0 | 0 | 2 |
| Weight(kg) | AT-150 | AT-250 | Control | Total |
|---|---|---|---|---|
| Mean | 75.6 ± 11.3 | 77.1 ± 14.5 | 71.4 ± 28.2 | 75.4 ± 16.2 |
| Height(cm) | AT-150 | AT-250 | Control | Total |
|---|---|---|---|---|
| Mean | 163 ± 4.2 | 169 ± 14.1 | 161 ± 13.7 | 165 ± 11.1 |
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