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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01090115
• Other study ID #: 2-001
• Status: Withdrawn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• Status: Withdrawn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