Disseminated Intravascular CoagulationPhase 2NCT00506519
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
A Phase 2 study testing Antithrombin alfa (INN name) in people with Disseminated Intravascular Coagulation, run by LEO Pharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disseminated Intravascular Coagulation
- What is being tested?
- Antithrombin alfa (INN name)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent has been obtained from the patient or his/her legally acceptable representative
- Severe sepsis
- Disseminated intravascular coagulation
Who cannot join
None listed.
About this study
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
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.
- Conditions
- Disseminated Intravascular Coagulation
- Being tested
- Antithrombin alfa (INN name), Control (Standard treatment)
- Keywords
- DIC associated with severe sepsis
- Medical subject headings
- Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin alfa (INN name)Drug
Control (Standard treatment)Drug
| Study group | Role | What they receive |
|---|---|---|
| AT-150 | Experimental | Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175% Receives: Drug: Antithrombin alfa (INN name) |
| AT-250 | Experimental | Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275% Receives: Drug: Antithrombin alfa (INN name) |
| Control | Active comparator | The best standard treatment for the underlying condition only Receives: Drug: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (11)
Mortality at Day 28
Measured: Day 28
Mortality at Day 90
Measured: 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.
Measured: 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
Measured: Baseline to Day 6
Days Alive and Out of ICU Day 28
Days alive and out of ICU at day 28 for all patients
Measured: Baseline to Day 28
Days Alive and Out of Hospital Day 28
Days alive and out of Hospital at day 28 for all patients
Measured: 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
Measured: Baseline to Day 28
Days Alive and Off Ventilator Day 28
Days alive and free of mechanical ventilation at day 28 for all patients
Measured: 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
Measured: Baseline to Day 28
Change From Baseline to Day 6 in Inflammation Marker IL-6
Measured: Baseline to Day 6
Change From Baseline to Day 6 in Inflammation Marker Procalcitonin
Measured: Baseline to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disseminated Intravascular CoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506519
- Sponsor's protocol ID
- LEO 90010-I21
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2007
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00506519
- Acronym / sponsor ID
- LEO 90010-I21
- Conditions
- Disseminated Intravascular Coagulation
- Keywords
- DIC associated with severe sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AT-150 | Experimental | Drug: Antithrombin alfa (INN name)Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175% |
| AT-250 | Experimental | 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% |
| Control | Active comparator | Drug: Control (Standard treatment)The best standard treatment for the underlying condition only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent has been obtained from the patient or his/her legally acceptable representative
- Severe sepsis
- Disseminated intravascular coagulation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithrombin alfa (INN name) | Drug | AT-150, AT-250 |
| Control (Standard treatment) | Drug | Control |
Primary outcome
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.
11 secondary outcomes
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
Time frame: Baseline to Day 6
Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6
Time frame: Baseline to Day 6
Days Alive and Out of ICU Day 28
Time frame: Baseline to Day 28
Days Alive and Out of Hospital Day 28
Time frame: Baseline to Day 28
Days Alive and Free of Inotrope/Vasopressor Support Day 28
Time frame: Baseline to Day 28
Days Alive and Off Ventilator Day 28
Time frame: Baseline to Day 28
Days Alive and Free of Need for Renal Replacement Therapy Day 28
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Disseminated Intravascular Coagulation
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruiting
Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
Sepsis, Disseminated Intravascular Coagulation (DIC)
Active, not recruitingObservational study
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
Sepsis, Venous Thromboembolism
RecruitingPhase 1
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Sepsis, Coagulopathy
Not yet recruitingObservational study
EARLY DIAGNOSIS OF SEPTIC DIC
Disseminated Intravascular Coagulation (DIC), Reanimation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antithrombin alfa (INN name) in people with Disseminated Intravascular Coagulation, run by LEO Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.