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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

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.

Estimated Enrollment: 200
Study Start Date: July 2007
Study Completion Date: March 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent has been obtained from the patient or his/her legally acceptable representative
  • Severe sepsis
  • Disseminated intravascular coagulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lene L. Bech, LEO Pharma
ClinicalTrials.gov Identifier: NCT00506519     History of Changes
Other Study ID Numbers: LEO 90010-I21
Study First Received: July 23, 2007
Last Updated: August 23, 2010
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by LEO Pharma:
DIC associated with severe sepsis

Additional relevant MeSH terms:
Disseminated Intravascular Coagulation
Sepsis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Antithrombins
Antithrombin III
Antithrombin Proteins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014