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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Disseminated Intravascular Coagulation
Sepsis
Drug: ART-123
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • all cause mortality rate [ Time Frame: 28days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
placebo
Drug: placebo
0.01 ml/kg up to a volume of 1ml administered by IV boleus every 24 hours for 6 consecutive days
Experimental: 2
ART-123
Drug: ART-123
0.01ml/kg up to a volume of 1ml administered by IV boleus every 24 hours for six consecutive days

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of South Alabama
ClinicalTrials.gov Identifier: NCT01090115     History of Changes
Other Study ID Numbers: 2-001
Study First Received: March 17, 2010
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disseminated Intravascular Coagulation
Sepsis
Toxemia
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014