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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 23, 2007
Last Updated Date	August 23, 2010
Start Date ^ICMJE	July 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: July 23, 2007)	Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00506519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 23, 2007)	Mortality at 28 and 90 days. Change in organ failure score and DIC score. Pharmacokinetic (PK) parameters.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
Official Title ^ICMJE	Exploratory Efficacy and Safety, Pharmacokinetics and Dose Finding Study of ATryn® (Antithrombin Alfa) in Patients With Disseminated Intravascular Coagulation Associated With Severe Sepsis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Disseminated Intravascular Coagulation
Intervention ^ICMJE	Drug: antithrombin alfa (INN name)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	200
Completion Date	March 2009
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Signed informed consent has been obtained from the patient or his/her legally acceptable representative Severe sepsis Disseminated intravascular coagulation
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00506519
Other Study ID Numbers ^ICMJE	LEO 90010-I21
Has Data Monitoring Committee	Yes
Responsible Party	Lene L. Bech, LEO Pharma
Study Sponsor ^ICMJE	LEO Pharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	LEO Pharma
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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