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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01090115
Other study ID # 2-001
Secondary ID
Status Withdrawn
Phase Phase 2
First received March 17, 2010
Last updated January 23, 2013
Start date March 2008
Est. completion date October 2008

Study information

Verified date January 2013
Source University of South Alabama
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms

  • Disseminated Intravascular Coagulation
  • Sepsis

Intervention

Drug:
ART-123
0.01ml/kg up to a volume of 1ml administered by IV boleus every 24 hours for six consecutive days
placebo
0.01 ml/kg up to a volume of 1ml administered by IV boleus every 24 hours for 6 consecutive days

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of South Alabama Artisian Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality rate 28days Yes
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