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

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ClinicalTrials.gov Identifier: NCT00506519
Recruitment Status : Terminated
First Posted : July 25, 2007
Last Update Posted : August 24, 2010
Sponsor:
Information provided by:
LEO Pharma

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.

Condition or disease Intervention/treatment Phase
Disseminated Intravascular Coagulation Drug: antithrombin alfa (INN name) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2007
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources




Primary Outcome Measures :
  1. Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.

Secondary Outcome Measures :
  1. Mortality at 28 and 90 days. Change in organ failure score and DIC score. Pharmacokinetic (PK) parameters.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Responsible Party: Lene L. Bech, LEO Pharma
ClinicalTrials.gov Identifier: NCT00506519     History of Changes
Other Study ID Numbers: LEO 90010-I21
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010

Keywords provided by LEO Pharma:
DIC associated with severe sepsis

Additional relevant MeSH terms:
Sepsis
Disseminated Intravascular Coagulation
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants