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This study has been withdrawn prior to enrollment.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
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: 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 July 31, 2014