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

This study has been terminated.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00506519
First received: July 23, 2007
Last updated: August 23, 2010
Last verified: August 2010

July 23, 2007
August 23, 2010
July 2007
Not Provided
Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.
Same as current
Complete list of historical versions of study NCT00506519 on ClinicalTrials.gov Archive Site
Mortality at 28 and 90 days. Change in organ failure score and DIC score. Pharmacokinetic (PK) parameters.
Same as current
Not Provided
Not Provided
 
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Disseminated Intravascular Coagulation
Drug: antithrombin alfa (INN name)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
March 2009
Not Provided

Inclusion Criteria:

  • Signed informed consent has been obtained from the patient or his/her legally acceptable representative
  • Severe sepsis
  • Disseminated intravascular coagulation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00506519
LEO 90010-I21
Yes
Lene L. Bech, LEO Pharma
LEO Pharma
Not Provided
Not Provided
LEO Pharma
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP