Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
|ClinicalTrials.gov Identifier: NCT00506519|
Recruitment Status : Terminated
First Posted : July 25, 2007
Last Update Posted : August 24, 2010
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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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Completion Date :||March 2009|
Primary Outcome Measures :
- Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.
Secondary Outcome Measures :
- Mortality at 28 and 90 days. Change in organ failure score and DIC score. Pharmacokinetic (PK) parameters.
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