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

NCT00506519 | Terminated Phase 2 Results DMC

• 1 other identifier: LEO 90010-I21
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Disseminated Intravascular Coagulation

Keywords

DIC associated with severe sepsis

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 28

Secondary Outcomes (11)

• 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

Study Arms (3)

AT-150

EXPERIMENTAL

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)

AT-250

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

The best standard treatment for the underlying condition only

Drug: Control (Standard treatment)

Interventions

Antithrombin alfa (INN name) DRUG

AT-150; AT-250

Control (Standard treatment) DRUG

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• LEO Pharma: lead

MeSH Terms

Conditions

Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia

Results Point of Contact

• Title: Disclosure
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 44 94 58 88

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 7, 2025
• Results First Posted: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share