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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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

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

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 groups in NCT00506519
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.

Jul 2007Mar 2009

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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
Not yet recruitingObservational study
Fluorescent Leukocytes as a Marker of Early Sepsis/Severity
Sepsis, Disseminated Intravascular Coagulation (DIC)
Not yet recruitingObservational study
Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy
Hematologic Neoplasms, Solid Tumor Metastatic Cancer Advanced Cancer

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