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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Exploratory Efficacy and Safety, Pharmacokinetics and Dose Finding Study of ATryn® (Antithrombin Alfa) in Patients With Disseminated Intravascular Coagulation Associa

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 Summary:
Sponsor: LEO Pharma

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

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: LEO Pharma

Dates:
Date Received: July 23, 2007
Date Started: July 2007
Date Completion:
Last Updated: August 23, 2010
Last Verified: August 2010