Clinical Trials Directory

Trials / Terminated

TerminatedNCT00506519

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
25 (actual)
Sponsor
LEO Pharma · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAntithrombin alfa (INN name)
DRUGControl (Standard treatment)

Timeline

Start date
2007-07-01
Primary completion
2009-03-01
Completion
2009-03-01
First posted
2007-07-25
Last updated
2025-03-07
Results posted
2021-08-31

Source: ClinicalTrials.gov record NCT00506519. Inclusion in this directory is not an endorsement.

Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis (NCT00506519) · Clinical Trials Directory