Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Phase 2

Suspended

• Conditions: Severe Sepsis
• Interventions: Drug: Talactoferrin alfa; Drug: Placebo

• Registration Number: NCT01273779
• Lead Sponsor: Agennix

Brief Summary

Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Study Start: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03
• Primary Completion: 2014-01
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

• Age greater than or equal to 18 years
• Onset of severe sepsis within the previous 24 hours
• Must be receiving antibiotic therapy
• Informed consent form signed by patient or authorized representatives according to local rules or regulations
• Able to take liquid medication by mouth or feeding tube

Exclusion Criteria

• Receipt of investigational medication within 4 weeks prior to participation in the study
• Pregnant or breast-feeding
• Severe congestive heart failure
• Known severe HIV infection
• Presence of severe burns
• Patients on high dose immunosuppressants
• Patients whose death is considered imminent
• Patients whose life expectancy for concurrent illness is less than 6 months
• Severe hypoxic encephalopathy or persistent vegetative state
• Severe liver disease
• Chronically bed bound
• Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talactoferrin alfa	Talactoferrin alfa	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
All Cause Mortality	28 Days

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality	12 months
Assess Safety and Tolerability	28 days

Trial Locations

Locations (99)

University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Providence Hospital; 🇺🇸 Mobile, Alabama, United States

Maricopa Medical Center; 🇺🇸 Maricopa, Arizona, United States

St. Joseph Hospital; 🇺🇸 Orange, California, United States

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

Stanford University Hospital; 🇺🇸 Stanford, California, United States

UCLA Medical Center; 🇺🇸 Sylmar, California, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States

Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States

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