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| Sponsored by: |
LEO Pharma |
|---|---|
| Information provided by: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT00506519 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Disseminated Intravascular Coagulation |
Drug: antithrombin alfa (INN name) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2007 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Lene L. Bech | +4544945888 | lene.bech@leo-pharma.com |
| Contact: Irene Rasmussen | +4544945888 | irene.rasmussen@leo-pharma.com |
| Canada | |
| Charles Lemoyne Hospital | Recruiting |
| Quebec, Canada, J4V 2H1 | |
| Contact: Germain Poirier, MD +14504665000 ext 2880 gpoirier72@hotmail.com | |
| Principal Investigator: Germain Poirier, MD | |
| France | |
| Service de Réanimation Polyvalente, CHRU Hôpital Roger Salengro | Recruiting |
| Lille Cedex, France, 59037 | |
| Contact: Francois Fourrier, MD +33320446435 f-fourrier@chru-lille.fr | |
| Principal Investigator: Francois Fourrier, MD | |
| Germany | |
| Abteilung Anästhesiologie II - Operative Intensivmedizin, Georg-August-Universität Göttingen | Recruiting |
| Göttingen, Germany, 37075 | |
| Contact: Michael Quintel, MD +49551396027 mquintel@zari.de | |
| Principal Investigator: Michael Quintel, MD | |
| United Kingdom | |
| Critical Care Unit, University College Hospital | Recruiting |
| London, United Kingdom, NW1 2BU | |
| Contact: Geoff Bellingan, MD +442073809008 geoff.bellingan@2uclh.nhs.uk | |
| Principal Investigator: Geoff Bellingan, MD | |
| Principal Investigator: | Geoff Bellingan, MD | Critical Care Unit, University College Hospital |
More Information
| Responsible Party: | LEO Pharma ( Lene L. Bech ) |
| Study ID Numbers: | LEO 90010-I21 |
| Study First Received: | July 23, 2007 |
| Last Updated: | April 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00506519 |
| Health Authority: | Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
DIC associated with severe sepsis |
|
Systemic Inflammatory Response Syndrome Signs and Symptoms Disseminated Intravascular Coagulation Sepsis Hemorrhagic Disorders Hematologic Diseases |
Thrombophilia Blood Coagulation Disorders Hemostatic Disorders Antithrombin III Inflammation |
|
Serine Proteinase Inhibitors Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Enzyme Inhibitors Infection Pharmacologic Actions Protease Inhibitors |
