Study to Look at the Effects of ART-123 on Patients With Sepsis and Disseminated Intravascular Coagulation (DIC)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Artisian Pharmaceuticals
Information provided by (Responsible Party):
University of South Alabama
ClinicalTrials.gov Identifier:
NCT01090115
First received: March 17, 2010
Last updated: January 23, 2013
Last verified: January 2013

March 17, 2010
January 23, 2013
March 2008
October 2008   (final data collection date for primary outcome measure)
all cause mortality rate [ Time Frame: 28days ] [ Designated as safety issue: Yes ]
Evaluate safety and efficacy of ART-123 in reducing mortality in DIC subjects due to sepsis [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01090115 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Look at the Effects of ART-123 on Patients With Sepsis and Disseminated Intravascular Coagulation (DIC)
A Randomized, Double-Blind, Placebo-Controlled Phase 2B Study ot Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular Coagulation

To evaluate the safety and activity of ART-123 in reducing death in subjects with sepsis and disseminated intravascular coagulation.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Disseminated Intravascular Coagulation
  • Sepsis
  • Drug: ART-123
    0.01ml/kg up to a volume of 1ml administered by IV boleus every 24 hours for six consecutive days
  • Drug: placebo
    0.01 ml/kg up to a volume of 1ml administered by IV boleus every 24 hours for 6 consecutive days
  • Placebo Comparator: 1
    placebo
    Intervention: Drug: placebo
  • Experimental: 2
    ART-123
    Intervention: Drug: ART-123
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Bacterial or suspected bacterial infection
  2. Presents with 2 or more sepsis related SIRS criteria within 24hours prior to any particular qualifying DIC score.

Exclusion Criteria:

  1. Pregnant
  2. Unwilling to allow transfusion of blood or blood products
  3. Body weight> or equal to 175kg.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01090115
2-001
Not Provided
University of South Alabama
University of South Alabama
Artisian Pharmaceuticals
Not Provided
University of South Alabama
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP